[Federal Register Volume 82, Number 131 (Tuesday, July 11, 2017)]
[Notices]
[Pages 31976-32002]
[FR Doc No: 2017-14453]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-1129]

Medical Devices; Exemptions From Premarket Notification: Class II
Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
a list of class II devices that the Agency has determined based on
established factors to no longer require premarket notification to
provide reasonable assurance of safety and effectiveness, subject to
certain limitations. FDA is publishing this notice of that
determination in accordance with procedures established by the 21st
Century Cures Act. This notice represents FDA's final determination
with respect to the list of class II devices proposed in a March 14,
2017, Federal Register document. The exemptions in this notice will
decrease regulatory burdens on the medical device industry and will
eliminate private costs and expenditures required to comply with
certain Federal regulations.

FOR FURTHER INFORMATION CONTACT: Bryce Bennett, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5244, Silver Spring, MD 20993, email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of March 14, 2017 (82 FR 13609), FDA issued
a notice proposing to exempt a list of class II devices from the
premarket notification requirements under section 510(k) of the Federal
Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360(k)), subject
to certain limitations. This notice was issued in accordance with the
21st Century Cures Act (Pub. L. 114-255), which was signed into law on
December 13, 2016. Section 3054 of that statute amended section 510(m)
of the FD&C Act. As amended, section 510(m)(1)(A) of the FD&C Act
provides that, within 90 days after enactment of the 21st Century Cures
Act and at least once every 5 years thereafter, FDA must publish in the
Federal Register a notice containing a list of each type of class II
device that FDA determines no longer requires a report under section
510(k) of the FD&C Act (generally referred to as a premarket
notification or ``510(k)'') to provide reasonable assurance of safety
and effectiveness. Within 210 days of enactment of the 21st Century
Cures Act, FDA must publish in the Federal Register a list representing
its final determination regarding the list of devices proposed in the
March 14, 2017, notice. Section 510(m)(3) of the FD&C Act provides that
upon the date that this final list is published in the Federal
Register, a 510(k) will no longer be required for the listed devices
and the applicable classification regulation for these devices shall be
deemed amended to incorporate such exemption. Interested persons were
given until May 15, 2017, to comment on the proposed list of class II
devices. After reviewing these comments and considering whether the
proposed list should be modified, FDA is now identifying its final
determination as to which of those devices are now exempt from
premarket notification requirements, subject to certain limitations, as
indicated in tables 1 to 3 of this notice.
    In a future action, FDA intends to amend the codified language for
each listed device's classification regulation to reflect this final
determination. Persons with pending 510(k) submissions for devices that
are now exempt from premarket notification, subject to the limitations
on exemptions, should withdraw their submissions.
    These exemptions will decrease regulatory burdens on the medical
device industry and will eliminate private costs and expenditures
required to comply with Federal regulation. Specifically, regulated
industry will no longer have to invest time and resources in premarket
notifications, including preparation of documents and data for
submission to FDA, payment of user fees associated with 510(k)
submissions, and responding to questions and requests for additional
information from FDA during 510(k) review.

II. Criteria for Exemption

    There are a number of factors FDA may consider to determine whether
a 510(k) is necessary to provide reasonable assurance of the safety and
effectiveness of a class II device. These factors are discussed in the
January 21, 1998, Federal Register notice (63 FR 3142) and subsequently
in the guidance the Agency issued on February 19, 1998, entitled
``Procedures for Class II Device Exemptions from Premarket
Notification, Guidance for Industry and CDRH Staff'' (``Class II 510(k)
Exemption Guidance'') (Ref. 1).

III. Limitations on Exemptions

    FDA believes that the types of class II devices listed in this
notice should be exempt from the premarket notification requirements
found under section 510(k) of the FD&C Act. However, an exemption from
the requirement of premarket notification does not mean that the device
is exempt from any other statutory or regulatory requirements, unless
such exemption is explicitly provided by order or regulation. FDA's
determination that premarket notification is unnecessary to provide a
reasonable assurance of safety and effectiveness for devices listed in
this document is based, in part, on the assurance of safety and
effectiveness that other regulatory controls, such as current good
manufacturing practice requirements, provide.
    In addition to being subject to the general limitations to the
exemptions found in Title 21 of the Code of Federal Regulations (CFR)
sections 862.9 to 892.9 (Sec. Sec.  862.9 to 892.9), when Agency
assessment determines that the factors laid out in the Class II 510(k)
Exemption Guidance (Ref. 1) do not weigh in favor of exemption for all
devices in a particular group, FDA may partially limit the exemption
from premarket notification requirements to specific devices within a
listed device type. In such situations where a partial exemption
limitation has been identified, FDA has determined that premarket
notification is necessary to provide a reasonable assurance of safety
and effectiveness for these devices. Partial exemption limitations can
be found in table 2 of this notice. FDA has assigned new product codes
to the device types that are now exempt subject to the partial
limitations in order to ensure that these devices can be separated from
devices that do not fall within the partial exemption limitation under
the existing product code (i.e., exempt and non-exempt devices within a
device type will have distinct product codes). If table 2 indicates
that a partial exemption limitation does apply to a device, then
affected device manufacturers should review their registration and
listing information to assess if they should list their device using
the original classification product code, which requires premarket
notification, or the new classification product code for the subset of
that device type that is now 510(k) exempt (subject to the general
limitations to the exemptions found in Sec. Sec.  862.9 to 892.9). In
table 2, for example, FDA is listing the exemption of the tympanometer
but limits the exemption to such devices that are in compliance with
FDA-recognized consensus standard ANSI S3.39. Tympanometers that comply
with this partial exemption limitation and the corresponding general
limitations in Sec.  874.9 are now exempt from the 510(k) requirements
and should be identified under new product code ``PTP'' in subsequent
registration and listing submissions. However, tympanometers not in
compliance with each of these exemption limitations remain subject to
the 510(k) requirements and will retain product code ``NAS.'' We
recommend that device manufacturers document in their records any
changes in the product code of their device with appropriate
justification.

IV. List of Class II Devices

    In table 1, FDA is identifying the following list of class II
devices that no longer require premarket notification under section
510(k) of the FD&C Act, subject to the general limitations to the
exemptions found in Sec. Sec.  862.9 to 892.9:

                        Table 1--Class II Devices
------------------------------------------------------------------------
      21 CFR section               Device type            Product code
------------------------------------------------------------------------
862.1020..................  Acid Phosphatase,          CJN
                             Nitrophenylphosphate.
862.1020..................  Acid Phosphatase, Thymol   CJR
                             Blue Monophosphate.
862.1020..................  Acid Phosphatase,          CJX
                             Disodium Phenylphosphate.
862.1020..................  Acid Phosphatase,          CKB
                             Naphthyl Phosphate.
862.1020..................  Acid Phosphatase,          CKE
                             Thymolphthale
                             Inmonophosphate.
862.1020..................  Acid Phosphatase, Beta     CKH
                             Glycerophosphate.
862.1020..................  Acid Phosphatase           JFH
                             (Prostatic), Tartrate
                             Inhibited.
862.1090..................  Radioassay, Angiotensin    KQN
                             Converting Enzyme.
862.1100..................  Vanillin Pyruvate, AST/    CIF
                             SGOT.
862.1100..................  Diazo, AST/SGOT..........  CIQ
862.1100..................  Hydrazone Colorimetry,     CIS
                             AST/SGOT.
862.1100..................  NADH Oxidation/NAD         CIT
                             Reduction, AST/SGOT.
862.1150..................  Calibrator, Primary......  JIS
862.1150..................  Calibrator, Secondary....  JIT
862.1150..................  Calibrator, Surrogate....  JIW
862.1150..................  Calibrator, Multi-Analyte  JIX
                             Mixture.
862.1345..................  Drink, Glucose Tolerance.  MRV
862.1350..................  Continuous Glucose         PJT
                             Monitor Secondary
                             Display.
862.1445..................  Chromatographic            CEX
                             Separation, Lactate
                             Dehydrogenase Isoenzymes.
862.1445..................  Electrophoretic, Lactate   CFE
                             Dehydrogenase Isoenzymes.
862.1445..................  Differential Rate Kinetic  JGF
                             Method, Lactate
                             Dehydrogenase Isoenzymes.
862.1509..................  System, Test, Urinary      LPT
                             Methylmalonic Acid.
862.1685..................  Radioimmunoassay,          CEE
                             Thyroxine-Binding
                             Globulin.
862.1700..................  Radioimmunoassay, Total    CDX
                             Thyroxine.
862.1700..................  Enzyme Immunoassay, Non-   KLI
                             Radiolabeled, Total
                             Thyroxine.
862.2265..................  High Throughput DNA        PFF
                             Sequence Analyzer.
862.2570..................  Instrumentation For        NSU
                             Clinical Multiplex Test
                             Systems.
862.2570..................  Real Time Nucleic Acid     OOI
                             Amplification System.
862.2570..................  Mass Spectrometer For      OTA
                             Clinical Multiplex Test
                             Systems.
862.2570..................  Micro Total Analysis       OUE
                             Instrument System.
862.2570..................  Complete Gene Expression   OVA
                             Profiling Accessory
                             Reagents.
862.2570..................  DNA Genetic Analyzer.....  PCA
862.2570..................  Data Acquisition Software  PQQ
862.3200..................  Calibrators, Drug Mixture  DKB
862.3200..................  Calibrators, Drug          DLJ
                             Specific.

862.3200..................  Calibrators, Ethyl         DNN
                             Alcohol.
864.5400..................  Fibrometer...............  GIE
864.5400..................  Timer, Coagulation.......  JBT
864.5425..................  Control, Plasma, Abnormal  GGC
864.5425..................  Plasma, Coagulation        GGN
                             Control.
864.5425..................  Plasma, Control, Normal..  GIZ
864.6550..................  Control, Fecal Occult      OSL
                             Blood.
864.6650..................  Study, Platelet Adhesive.  JBZ
864.7275..................  Test, Euglobulin Lysis...  JBO
864.7300..................  Fibrin Monomer             JBN
                             Paracoagulation.
864.7340..................  Fibrinogen Standard......  GFX
864.7340..................  Plasma, Fibrinogen         GIL
                             Control.
864.7375..................  Glutathione, Red-Cell....  GII
864.7375..................  Fluorescence, Visual       JMH
                             Observation (Qual.,
                             U.V.), Glutathione
                             Reductase.
864.7375..................  Assay, Glutathione         KQF
                             Reductase.
864.7415..................  Control, Hemoglobin,       JCM
                             Abnormal.
864.7455..................  Stain, Fetal Hemoglobin..  GHQ
864.7500..................  Acid Hematin.............  GGF
864.7720..................  Test, Prothrombin          GGQ
                             Consumption.
864.7735..................  Prothrombin-Proconvertin   JPF
                             and Thrombotest.
864.8150..................  Calibrator for Cell        KRX
                             Indices.
864.8165..................  Calibrator for Hemoglobin  KRZ
                             and Hematocrit
                             Measurement.
864.8175..................  Calibrator for Platelet    KRY
                             Counting.
864.8185..................  Calibrator for Red-Cell    KSA
                             and White-Cell Counting.
864.8625..................  Standards and Controls,    GFS
                             Hemoglobin, Normal and
                             Abnormal.
864.8625..................  Control, White-Cell......  GGL
864.8625..................  Control, Hemoglobin......  GGM
864.8625..................  Control, Platelet........  GJP
864.8625..................  Control, Red-Cell........  GJR
864.8625..................  Control, Hematocrit......  GLK
864.8625..................  Mixture, Control, White-   GLQ
                             Cell and Red-Cell
                             Indices.
864.8625..................  Control, Cell Counter,     JCN
                             Normal and Abnormal.
864.8625..................  Mixture, Hematology        JPK
                             Quality Control.
864.8625..................  Material, Quality          NRF
                             Control, Semen Analysis.
864.8625..................  Control Material, Blood    NRS
                             Circulating Epithelial
                             Cancer Cell.
864.9400..................  Solution, Stabilized       KSK
                             Enzyme.
866.3395..................  Norovirus Serological      OUC
                             Reagents.
866.5210..................  Immunochemical,            CHN
                             Ceruloplasmin.
866.5210..................  Ceruloplasmin, Rhodamine,  DCT
                             Antigen, Antiserum,
                             Control.
866.5210..................  Ceruloplasmin, FITC,       DCY
                             Antigen, Antiserum,
                             Control.
866.5210..................  Ceruloplasmin, Antigen,    DDB
                             Antiserum, Control.
866.5210..................  P-Phenyl-Enediamine/EDTA   JFQ
                             (Spectrophotometric),
                             Ceruloplasmin.
866.5210..................  Indirect Copper Assay,     JFR
                             Ceruloplasmin.
866.5470..................  Hemoglobin, Chain          DAM
                             Specific, Antigen,
                             Antiserum, Control.
866.5620..................  Alpha-2-Macroglobulin,     DDT
                             Rhodamine, Antigen,
                             Antiserum, Control.
866.5620..................  Alpha-2-Macroglobulin,     DDY
                             FITC, Antigen,
                             Antiserum, Control.
866.5620..................  Alpha-2-Macroglobulin,     DEB
                             Antigen, Antiserum,
                             Control.
866.5630..................  System, Test, Beta-2-      JZG
                             Microglobulin
                             Immunological.
866.5910..................  Quality Control Material,  NZB
                             Genetics, DNA.
868.1040..................  Algesimeter, Powered.....  BSI
868.1400..................  Legging, Compression, Non- LLK
                             Inflatable.
868.2500..................  Monitor, Oxygen,           KLK
                             Cutaneous, For Infant
                             Not Under Gas Anesthesia.
868.2500..................  Monitor, Oxygen,           LPP
                             Cutaneous, For Uses
                             Other Than For Infant
                             Not Under Gas Anesthesia.
868.2550..................  Pneumotachometer.........  JAX
868.5180..................  Bed, Rocking, Breathing    CCO
                             Assist.
868.6250..................  Compressor, Air, Portable  BTI
870.1390..................  Trocar...................  DRC
870.1875..................  Lung Sound Monitor.......  OCR
870.2675..................  Oscillometer.............  DRZ
870.4280..................  Filter, Prebypass,         KRJ
                             Cardiopulmonary Bypass.
870.4290..................  Adaptor, Stopcock,         DTL
                             Manifold, Fitting,
                             Cardiopulmonary Bypass.
870.4340..................  Monitor and/or Control,    DTW
                             Level Sensing,
                             Cardiopulmonary Bypass.
870.4420..................  Sucker, Cardiotomy         DTS
                             Return, Cardiopulmonary
                             Bypass.
870.4430..................  Suction Control,           DWD
                             Intracardiac,
                             Cardiopulmonary Bypass.
872.1720..................  Tester, Pulp.............  EAT
872.3260..................  External Cleaning          PME
                             Solution.
872.3300..................  Coating, Denture           EBE
                             Hydrophilic, Resin.
872.3540..................  Pad, Denture, Over The     EHR
                             Counter.
872.3540..................  Cushion, Denture, Over     EHS
                             The Counter.
872.3560..................  Reliner, Denture, Over     EBP
                             The Counter.
872.3590..................  Denture, Plastic, Tooth..  ELM

872.3600..................  Denture Preformed          EKO
                             (Partially Prefabricated
                             Denture).
872.3890..................  Splint, Endodontic         ELS
                             Stabilizing.
872.5550..................  Ring, Teething, Fluid-     KKO
                             Filled.
872.6770..................  Syringe, Cartridge.......  EJI
874.1120..................  Generator, Electronic      ETS
                             Noise (for Audiometric
                             Testing).
874.1325..................  Electroglottograph.......  KLX
874.3310..................  Calibrator, Hearing Aid/   ETW
                             Earphone and Analysis
                             Systems.
874.3320..................  Hearing Aid, Group and     EPF
                             Auditory Trainer.
874.3320..................  Device, Assistive          LZI
                             Listening.
874.3330..................  Hearing Aid, Master......  KHL
874.3430..................  Mold, Middle-Ear.........  ETC
874.3730..................  Device, Voice              MCK
                             Amplification.
876.1500..................  Light Source,              FCQ
                             Incandescent, Diagnostic.
876.1500..................  Light Source,              FCR
                             Photographic, Fiberoptic.
876.1500..................  Light Source, Fiberoptic,  FCW
                             Routine.
876.1500..................  Carrier, Sponge,           FGS
                             Endoscopic.
876.1500..................  Light Source, Endoscope,   GCT
                             Xenon Arc.
876.1500..................  Transformer, Endoscope...  GCW
876.1500..................  LED Light Source.........  NTN
876.1500..................  Endoscopic Guide Wire,     OCY
                             Gastroenterology-Urology.
876.4020..................  Light, Catheter,           FCS
                             Fiberoptic, Glass,
                             Ureteral.
876.4270..................  Rod, Colostomy...........  EZP
876.4400..................  Ligator, Hemorrhoidal....  FHN
876.4400..................  Ligator, Esophageal......  MND
876.4500..................  Lithotriptor, Biliary      LQC
                             Mechanical.
876.4770..................  Urethrotome..............  EZO
876.5010..................  Bag, Bile Collecting.....  EXF
876.5025..................  Vibrator for Climax        PIA
                             Control of Premature
                             Ejaculation.
876.5365..................  Dilator, Esophageal        EZM
                             (Metal Olive) Gastro-
                             Urology.
876.5365..................  Bougie, Esophageal, and    FAT
                             Gastrointestinal, Gastro-
                             Urology.
876.5365..................  Dilator, Esophageal......  KNQ
876.5520..................  Dilator, Urethral........  KOE
876.5665..................  Disinfectant, Subsystem,   NIH
                             Water Purification.
876.5820..................  Set, Dialyzer Holder.....  FKI
876.5895..................  Irrigator, Ostomy........  EXD
876.5980..................  Catheter, Retention,       FGD
                             Barium Enema With Bag.
876.5980..................  Gastrostomy Tube Holder..  PLI
878.4370..................  Drape, Surgical, ENT.....  ERY
878.4370..................  Drape, Pure Latex Sheet,   EYX
                             With Self-Retaining
                             Finger Cot.
878.4370..................  Drape, Urological,         EYY
                             Disposable.
878.4370..................  Pad, Kelly...............  FNW
878.4370..................  Drape, Patient,            HMT
                             Ophthalmic.
878.4370..................  Drape, Microscope,         HMW
                             Ophthalmic.
878.4370..................  Ring (Wound Protector),    KGW
                             Drape Retention,
                             Internal.
878.4580..................  Lamp, Operating-Room.....  FQP
878.4580..................  Light, Surgical,           FSQ
                             Instrument.
878.4580..................  Light, Surgical, Floor     FSS
                             Standing.
878.4580..................  Light, Surgical,           FSW
                             Endoscopic.
878.4580..................  Light, Surgical,           FSX
                             Connector.
878.4580..................  Light, Surgical, Ceiling   FSY
                             Mounted.
878.4580..................  Light, Surgical, Carrier.  FSZ
878.4580..................  Light, Surgical,           FTA
                             Accessories.
878.4580..................  Lamp, Surgical...........  FTD
878.4580..................  Illuminator, Remote......  FTG
878.4580..................  Lamp, Surgical,            GBC
                             Incandescent.
878.5070..................  Apparatus, Air Handling,   FZG
                             Bench.
878.5070..................  Apparatus, Air Handling,   FZH
                             Room.
878.5070..................  Apparatus, Air Handling,   FZI
                             Enclosure.
880.5580..................  Locator, Acupuncture       BWJ
                             Point.
880.5580..................  Needle, Acupuncture,       MQX
                             Single Use.
880.5780..................  Stocking, Medical Support  DWL
                             (to Prevent Pooling of
                             Blood in Legs).
882.1020..................  Analyzer, Rigidity.......  GZM
882.1540..................  Device, Galvanic Skin      GZO
                             Response Measurement.
882.1560..................  Device, Skin Potential     HCJ
                             Measurement.
882.1855..................  Encephalogram Telemetry    GYE
                             System.
882.5895..................  Vibratory Counter-         OVP
                             Stimulation.
884.2990..................  Sheet, Recording, Breast   NHM
                             Examination.
884.3200..................  Drain, Cervical..........  HFL
884.4400..................  Forceps, Obstetrical.....  HDA
884.4530..................  Clamp, Umbilical.........  HFW
884.4530..................  Speculum, Vaginal,         HIB
                             Nonmetal.

884.4530..................  Speculum, Vaginal,         HIC
                             Nonmetal, Fiberoptic.
884.4530..................  Clamp and Cutter,          NBZ
                             Umbilical.
884.4900..................  Table, Obstetrical, AC-    HDD
                             Powered (and
                             Accessories).
884.4900..................  Table, Obstetrical,        HHP
                             Manual (and Accessories).
884.4900..................  Table, Obstetric (and      KNC
                             Accessories).
884.5200..................  Hemorrhoid Prevention      OOA
                             Pressure Wedge.
884.5390..................  Heater, Perineal, Direct   HGZ
                             Contact.
884.5390..................  Heater, Perineal,          HHA
                             Radiant, Non-Contact.
884.5390..................  Heater, Perineal.........  KND
884.5400..................  Cup, Menstrual...........  HHE
884.5425..................  Pad, Menstrual, Scented..  HHL
884.6150..................  Micromanipulators and      MQJ
                             Microinjectors, Assisted
                             Reproduction.
886.1120..................  Photorefractor...........  MMF
886.1120..................  Camera, Ophthalmic,        PJZ
                             General-Use.
886.1250..................  Euthyscope, AC-Powered...  HMK
886.1570..................  Ophthalmoscope, AC-        HLI
                             Powered.
886.1570..................  Ophthalmoscope, Battery-   HLJ
                             Powered.
886.1570..................  Ophthalmoscopes,           MSG
                             Replacement Batteries,
                             Hand-Held.
886.1780..................  Retinoscope, AC-Powered..  HKL
886.1945..................  Transilluminator, AC-      HJM
                             Powered.
886.4150..................  Tubing, Replacement,       MSR
                             Phacofragmentation Unit.
886.4250..................  Unit, Electrolysis, AC-    HRO
                             Powered, Ophthalmic.
886.4335..................  Headlight, Fiberoptic      FCT
                             Focusing.
886.4335..................  Light, Headband, Surgical  FSR
886.4335..................  Headlamp, Operating, AC-   HPQ
                             Powered.
886.4400..................  Locator, Metal,            HPM
                             Electronic.
886.4440..................  Magnet, AC-Powered.......  HPO
886.4790..................  Sponge, Ophthalmic.......  HOZ
886.4790..................  Eye Tray.................  OJK
888.1240..................  Dynamometer, AC-Powered..  LBB
888.4580..................  Instrument, Surgical,      JDX
                             Sonic and Accessory/
                             Attachment.
888.4580..................  System, Cement Removal     LZV
                             Extraction.
890.1450..................  Hammer, Reflex, Powered..  IKO
890.5100..................  Bath, Hydro-Massage......  ILJ
890.5100..................  Bath, Sitz, Powered......  ILM
890.5110..................  Bath, Paraffin...........  IMC
890.5250..................  Cabinet, Moist Steam.....  IMB
890.5360..................  Exerciser, Measuring.....  ISD
890.5500..................  Lamp, Infrared,            ILY
                             Therapeutic Heating.
890.5575..................  Device, Warning,           IRN
                             Overload, External Limb,
                             Powered.
892.1000..................  MRI Disposable Kit.......  OIM
892.1560..................  Biopsy Needle Guide Kit..  OIJ
892.1610..................  Aperature, Radiographic..  IZS
892.1610..................  Cone, Radiographic.......  IZT
892.1610..................  Collimator, Automatic,     IZW
                             Radiographic.
892.1610..................  Collimator, Manual,        IZX
                             Radiographic.
892.1610..................  Device, Beam Limiting, X-  KPW
                             Ray, Diagnostic.
892.1650..................  Arthrogram Tray..........  OII
892.1650..................  Radiology Dental Tray....  OIK
892.1670..................  Device, Spot-Film........  IXL
892.1680..................  Radiographic Contrast      OIO
                             Tray.
892.1680..................  Radiology Diagnostic Kit.  OIP
892.1730..................  Discography Kit..........  OIL
892.1820..................  Chair,                     HBK
                             Pneumocephalographic.
892.1850..................  Cassette, Radiographic     IXA
                             Film.
892.1860..................  Changer, Radiographic      KPX
                             Film/Cassette.
892.1870..................  Programmer, Changer, Film/ IZP
                             Cassette, Radiographic.
892.1900..................  Controller, Temperature,   EGT
                             Radiographic.
892.1900..................  Dryer, Film, Radiographic  EGW
892.1900..................  Processor, Radiographic-   EGY
                             Film, Automatic, Dental.
892.1900..................  Processor, Radiographic-   IXW
                             Film, Automatic.
892.1900..................  Processor, Cine Film.....  IXX
892.2030..................  Digitizer, Image,          LMA
                             Radiological.
892.2030..................  Digitizer, Images,         NFH
                             Ophthalmic.
892.2040..................  Camera, Multi Format,      LMC
                             Radiological.
892.2040..................  Device, Hardcopy, Images,  NFI
                             Ophthalmic.
892.5730..................  Prostate Seeding Kit.....  OIN
------------------------------------------------------------------------

    In table 2, FDA is identifying a list of class II devices that no
longer require premarket notification under section 510(k) of the FD&C
Act, subject to the general limitations to the exemptions found in
Sec. Sec.  862.9 to 892.9, as well as the indicated partial exemption
limitations. Devices listed in table 2 are now exempt, but only if they
are in concurrent compliance with both the partial exemption limitation
specified in table 2 and its corresponding general limitation found in
the .9 section of Parts 862 to 892 of Title 21 of the CFR.

                                            Table 2--Class II Devices
----------------------------------------------------------------------------------------------------------------
                                                      Exempt product    Former  product      Partial exemption
         21 CFR Section             Device type            code        code (non-exempt)        limitation
----------------------------------------------------------------------------------------------------------------
862.3100.......................  Enzyme             PUX..............  DKZ..............  Exemption is limited
                                  Immunoassay,                                             to test systems
                                  Amphetamine.                                             intended for
                                                                                employment and
                                                                                insurance testing
                                                                                that include a
                                                                                statement in their
                                                                                labeling that the
                                                                                device is intended
                                                                                solely for use in
                                                                                employment and
                                                                                insurance testing,
                                                                                and does not include
                                                                                test systems intended
                                                                                for Federal drug
                                                                                testing programs
                                                                                (e.g., programs run
                                                                                by the Substance
                                                                                Abuse and Mental
                                                                                Health Services
                                                                                Administration
                                                                                (SAMHSA), the
                                                                                Department of
                                                                                Transportation (DOT),
                                                                                and the U.S.
                                                                                military.)
862.3100.......................  Radioimmunoassay,  PUX..............  DJP..............  Exemption is limited
                                  Amphetamine.                                             to test systems
                                                                                intended for
                                                                                employment and
                                                                                insurance testing
                                                                                that include a
                                                                                statement in their
                                                                                labeling that the
                                                                                device is intended
                                                                                solely for use in
                                                                                employment and
                                                                                insurance testing,
                                                                                and does not include
                                                                                test systems intended
                                                                                for Federal drug
                                                                                testing programs
                                                                                (e.g., programs run
                                                                                by the Substance
                                                                                Abuse and Mental
                                                                                Health Services
                                                                                Administration
                                                                                (SAMHSA), the
                                                                                Department of
                                                                                Transportation (DOT),
                                                                                and the U.S.
                                                                                military.)
862.3100.......................  Thin Layer         PUX..............  DIT..............  Exemption is limited
                                  Chromatography,                                          to test systems
                                  Amphetamine.                                             intended for
                                                                                employment and
                                                                                insurance testing
                                                                                that include a
                                                                                statement in their
                                                                                labeling that the
                                                                                device is intended
                                                                                solely for use in
                                                                                employment and
                                                                                insurance testing,
                                                                                and does not include
                                                                                test systems intended
                                                                                for Federal drug
                                                                                testing programs
                                                                                (e.g., programs run
                                                                                by the Substance
                                                                                Abuse and Mental
                                                                                Health Services
                                                                                Administration
                                                                                (SAMHSA), the
                                                                                Department of
                                                                                Transportation (DOT),
                                                                                and the U.S.
                                                                                military.)
862.3100.......................  Gas                PUX..............  DOD..............  Exemption is limited
                                  Chromatography,                                          to test systems
                                  Amphetamine.                                             intended for
                                                                                employment and
                                                                                insurance testing
                                                                                that include a
                                                                                statement in their
                                                                                labeling that the
                                                                                device is intended
                                                                                solely for use in
                                                                                employment and
                                                                                insurance testing,
                                                                                and does not include
                                                                                test systems intended
                                                                                for Federal drug
                                                                                testing programs
                                                                                (e.g., programs run
                                                                                by the Substance
                                                                                Abuse and Mental
                                                                                Health Services
                                                                                Administration
                                                                                (SAMHSA), the
                                                                                Department of
                                                                                Transportation (DOT),
                                                                                and the U.S.
                                                                                military.)
862.3100.......................  Liquid             PUX..............  DNI..............  Exemption is limited
                                  Chromatography,                                          to test systems
                                  Amphetamine.                                             intended for
                                                                                employment and
                                                                                insurance testing
                                                                                that include a
                                                                                statement in their
                                                                                labeling that the
                                                                                device is intended
                                                                                solely for use in
                                                                                employment and
                                                                                insurance testing,
                                                                                and does not include
                                                                                test systems intended
                                                                                for Federal drug
                                                                                testing programs
                                                                                (e.g., programs run
                                                                                by the Substance
                                                                                Abuse and Mental
                                                                                Health Services
                                                                                Administration
                                                                                (SAMHSA), the
                                                                                Department of
                                                                                Transportation (DOT),
                                                                                and the U.S.
                                                                                military.)
862.3100.......................  Free Radical       PUX..............  DJL..............  Exemption is limited
                                  Assay,                                                   to test systems
                                  Amphetamine.                                             intended for
                                                                                employment and
                                                                                insurance testing
                                                                                that include a
                                                                                statement in their
                                                                                labeling that the
                                                                                device is intended
                                                                                solely for use in
                                                                                employment and
                                                                                insurance testing,
                                                                                and does not include
                                                                                test systems intended
                                                                                for Federal drug
                                                                                testing programs
                                                                                (e.g., programs run
                                                                                by the Substance
                                                                                Abuse and Mental
                                                                                Health Services
                                                                                Administration
                                                                                (SAMHSA), the
                                                                                Department of
                                                                                Transportation (DOT),
                                                                                and the U.S.
                                                                                military.)
862.3150.......................  Enzyme             PUY..............  DIS..............  Exemption is limited
                                  Immunoassay,                                             to test systems
                                  Barbiturate.                                             intended for
                                                                                employment and
                                                                                insurance testing
                                                                                that include a
                                                                                statement in their
                                                                                labeling that the
                                                                                device is intended
                                                                                solely for use in
                                                                                employment and
                                                                                insurance testing,
                                                                                and does not include
                                                                                test systems intended
                                                                                for Federal drug
                                                                                testing programs
                                                                                (e.g., programs run
                                                                                by the Substance
                                                                                Abuse and Mental
                                                                                Health Services
                                                                                Administration
                                                                                (SAMHSA), the
                                                                                Department of
                                                                                Transportation (DOT),
                                                                                and the U.S.
                                                                                military.)

862.3150.......................  Radioimmunoassay,  PUY..............  DKN..............  Exemption is limited
                                  Barbiturate.                                             to test systems
                                                                                intended for
                                                                                employment and
                                                                                insurance testing
                                                                                that include a
                                                                                statement in their
                                                                                labeling that the
                                                                                device is intended
                                                                                solely for use in
                                                                                employment and
                                                                                insurance testing,
                                                                                and does not include
                                                                                test systems intended
                                                                                for Federal drug
                                                                                testing programs
                                                                                (e.g., programs run
                                                                                by the Substance
                                                                                Abuse and Mental
                                                                                Health Services
                                                                                Administration
                                                                                (SAMHSA), the
                                                                                Department of
                                                                                Transportation (DOT),
                                                                                and the U.S.
                                                                                military.)
862.3150.......................  Thin Layer         PUY..............  DKX..............  Exemption is limited
                                  Chromatography,                                          to test systems
                                  Barbiturate.                                             intended for
                                                                                employment and
                                                                                insurance testing
                                                                                that include a
                                                                                statement in their
                                                                                labeling that the
                                                                                device is intended
                                                                                solely for use in
                                                                                employment and
                                                                                insurance testing,
                                                                                and does not include
                                                                                test systems intended
                                                                                for Federal drug
                                                                                testing programs
                                                                                (e.g., programs run
                                                                                by the Substance
                                                                                Abuse and Mental
                                                                                Health Services
                                                                                Administration
                                                                                (SAMHSA), the
                                                                                Department of
                                                                                Transportation (DOT),
                                                                                and the U.S.
                                                                                military.)
862.3150.......................  Mercury            PUY..............  DJN..............  Exemption is limited
                                  Dithiazone,                                              to test systems
                                  Colorimetry,                                             intended for
                                  Barbiturate.                                             employment and
                                                                                insurance testing
                                                                                that include a
                                                                                statement in their
                                                                                labeling that the
                                                                                device is intended
                                                                                solely for use in
                                                                                employment and
                                                                                insurance testing,
                                                                                and does not include
                                                                                test systems intended
                                                                                for Federal drug
                                                                                testing programs
                                                                                (e.g., programs run
                                                                                by the Substance
                                                                                Abuse and Mental
                                                                                Health Services
                                                                                Administration
                                                                                (SAMHSA), the
                                                                                Department of
                                                                                Transportation (DOT),
                                                                                and the U.S.
                                                                                military.)
862.3150.......................  Hemagglutination   PUY..............  DLX..............  Exemption is limited
                                  Inhibition,                                              to test systems
                                  Barbiturate.                                             intended for
                                                                                employment and
                                                                                insurance testing
                                                                                that include a
                                                                                statement in their
                                                                                labeling that the
                                                                                device is intended
                                                                                solely for use in
                                                                                employment and
                                                                                insurance testing,
                                                                                and does not include
                                                                                test systems intended
                                                                                for Federal drug
                                                                                testing programs
                                                                                (e.g., programs run
                                                                                by the Substance
                                                                                Abuse and Mental
                                                                                Health Services
                                                                                Administration
                                                                                (SAMHSA), the
                                                                                Department of
                                                                                Transportation (DOT),
                                                                                and the U.S.
                                                                                military.)
862.3150.......................  Gas Liquid         PUY..............  DMF..............  Exemption is limited
                                  Chromatography,                                          to test systems
                                  Barbiturate.                                             intended for
                                                                                employment and
                                                                                insurance testing
                                                                                that include a
                                                                                statement in their
                                                                                labeling that the
                                                                                device is intended
                                                                                solely for use in
                                                                                employment and
                                                                                insurance testing,
                                                                                and does not include
                                                                                test systems intended
                                                                                for Federal drug
                                                                                testing programs
                                                                                (e.g., programs run
                                                                                by the Substance
                                                                                Abuse and Mental
                                                                                Health Services
                                                                                Administration
                                                                                (SAMHSA), the
                                                                                Department of
                                                                                Transportation (DOT),
                                                                                and the U.S.
                                                                                military.)
862.3150.......................  High Pressure      PUY..............  KZY..............  Exemption is limited
                                  Liquid                                                   to test systems
                                  Chromatography,                                          intended for
                                  Barbiturate.                                             employment and
                                                                                insurance testing
                                                                                that include a
                                                                                statement in their
                                                                                labeling that the
                                                                                device is intended
                                                                                solely for use in
                                                                                employment and
                                                                                insurance testing,
                                                                                and does not include
                                                                                test systems intended
                                                                                for Federal drug
                                                                                testing programs
                                                                                (e.g., programs run
                                                                                by the Substance
                                                                                Abuse and Mental
                                                                                Health Services
                                                                                Administration
                                                                                (SAMHSA), the
                                                                                Department of
                                                                                Transportation (DOT),
                                                                                and the U.S.
                                                                                military.)
862.3170.......................  Enzyme             PUZ..............  JXM..............  Exemption is limited
                                  Immunoassay,                                             to test systems
                                  Benzodiazepine.                                          intended for
                                                                                employment and
                                                                                insurance testing
                                                                                that include a
                                                                                statement in their
                                                                                labeling that the
                                                                                device is intended
                                                                                solely for use in
                                                                                employment and
                                                                                insurance testing,
                                                                                and does not include
                                                                                test systems intended
                                                                                for Federal drug
                                                                                testing programs
                                                                                (e.g., programs run
                                                                                by the Substance
                                                                                Abuse and Mental
                                                                                Health Services
                                                                                Administration
                                                                                (SAMHSA), the
                                                                                Department of
                                                                                Transportation (DOT),
                                                                                and the U.S.
                                                                                military.)
862.3170.......................  High Pressure      PUZ..............  LAA..............  Exemption is limited
                                  Liquid                                                   to test systems
                                  Chromatography,                                          intended for
                                  Benzodiazepine.                                          employment and
                                                                                insurance testing
                                                                                that include a
                                                                                statement in their
                                                                                labeling that the
                                                                                device is intended
                                                                                solely for use in
                                                                                employment and
                                                                                insurance testing,
                                                                                and does not include
                                                                                test systems intended
                                                                                for Federal drug
                                                                                testing programs
                                                                                (e.g., programs run
                                                                                by the Substance
                                                                                Abuse and Mental
                                                                                Health Services
                                                                                Administration
                                                                                (SAMHSA), the
                                                                                Department of
                                                                                Transportation (DOT),
                                                                                and the U.S.
                                                                                military.)

862.3170.......................  Test,              PUZ..............  NFV..............  Exemption is limited
                                  Benzodiazepine,                                          to test systems
                                  Over The Counter.                                        intended for
                                                                                employment and
                                                                                insurance testing
                                                                                that include a
                                                                                statement in their
                                                                                labeling that the
                                                                                device is intended
                                                                                solely for use in
                                                                                employment and
                                                                                insurance testing,
                                                                                and does not include
                                                                                test systems intended
                                                                                for Federal drug
                                                                                testing programs
                                                                                (e.g., programs run
                                                                                by the Substance
                                                                                Abuse and Mental
                                                                                Health Services
                                                                                Administration
                                                                                (SAMHSA), the
                                                                                Department of
                                                                                Transportation (DOT),
                                                                                and the U.S.
                                                                                military.)
862.3170.......................  Gas                PUZ..............  KZZ..............  Exemption is limited
                                  Chromatography,                                          to test systems
                                  Benzodiazepine.                                          intended for
                                                                                employment and
                                                                                insurance testing
                                                                                that include a
                                                                                statement in their
                                                                                labeling that the
                                                                                device is intended
                                                                                solely for use in
                                                                                employment and
                                                                                insurance testing,
                                                                                and does not include
                                                                                test systems intended
                                                                                for Federal drug
                                                                                testing programs
                                                                                (e.g., programs run
                                                                                by the Substance
                                                                                Abuse and Mental
                                                                                Health Services
                                                                                Administration
                                                                                (SAMHSA), the
                                                                                Department of
                                                                                Transportation (DOT),
                                                                                and the U.S.
                                                                                military.)
862.3170.......................  Thin Layer         PUZ..............  LAB..............  Exemption is limited
                                  Chromatography,                                          to test systems
                                  Benzodiazepine.                                          intended for
                                                                                employment and
                                                                                insurance testing
                                                                                that include a
                                                                                statement in their
                                                                                labeling that the
                                                                                device is intended
                                                                                solely for use in
                                                                                employment and
                                                                                insurance testing,
                                                                                and does not include
                                                                                test systems intended
                                                                                for Federal drug
                                                                                testing programs
                                                                                (e.g., programs run
                                                                                by the Substance
                                                                                Abuse and Mental
                                                                                Health Services
                                                                                Administration
                                                                                (SAMHSA), the
                                                                                Department of
                                                                                Transportation (DOT),
                                                                                and the U.S.
                                                                                military.)
862.3250.......................  Enzyme             PVA..............  DIO..............  Exemption is limited
                                  Immunoassay,                                             to test systems
                                  Cocaine and                                              intended for
                                  Cocaine                                                  employment and
                                  Metabolites.                                             insurance testing
                                                                                that include a
                                                                                statement in their
                                                                                labeling that the
                                                                                device is intended
                                                                                solely for use in
                                                                                employment and
                                                                                insurance testing,
                                                                                and does not include
                                                                                test systems intended
                                                                                for Federal drug
                                                                                testing programs
                                                                                (e.g., programs run
                                                                                by the Substance
                                                                                Abuse and Mental
                                                                                Health Services
                                                                                Administration
                                                                                (SAMHSA), the
                                                                                Department of
                                                                                Transportation (DOT),
                                                                                and the U.S.
                                                                                military.)
862.3250.......................  Radioimmunoassay,  PVA..............  KLN..............  Exemption is limited
                                  Cocaine                                                  to test systems
                                  Metabolite.                                              intended for
                                                                                employment and
                                                                                insurance testing
                                                                                that include a
                                                                                statement in their
                                                                                labeling that the
                                                                                device is intended
                                                                                solely for use in
                                                                                employment and
                                                                                insurance testing,
                                                                                and does not include
                                                                                test systems intended
                                                                                for Federal drug
                                                                                testing programs
                                                                                (e.g., programs run
                                                                                by the Substance
                                                                                Abuse and Mental
                                                                                Health Services
                                                                                Administration
                                                                                (SAMHSA), the
                                                                                Department of
                                                                                Transportation (DOT),
                                                                                and the U.S.
                                                                                military.)
862.3250.......................  Enzyme             PVA..............  JXO..............  Exemption is limited
                                  Immunoassay,                                             to test systems
                                  Cocaine.                                                 intended for
                                                                                employment and
                                                                                insurance testing
                                                                                that include a
                                                                                statement in their
                                                                                labeling that the
                                                                                device is intended
                                                                                solely for use in
                                                                                employment and
                                                                                insurance testing,
                                                                                and does not include
                                                                                test systems intended
                                                                                for Federal drug
                                                                                testing programs
                                                                                (e.g., programs run
                                                                                by the Substance
                                                                                Abuse and Mental
                                                                                Health Services
                                                                                Administration
                                                                                (SAMHSA), the
                                                                                Department of
                                                                                Transportation (DOT),
                                                                                and the U.S.
                                                                                military.)
862.3250.......................  Hemagglutination,  PVA..............  DLN..............  Exemption is limited
                                  Cocaine                                                  to test systems
                                  Metabolites                                              intended for
                                  (Benzoylecgonine                                         employment and
                                  ).                                                       insurance testing
                                                                                that include a
                                                                                statement in their
                                                                                labeling that the
                                                                                device is intended
                                                                                solely for use in
                                                                                employment and
                                                                                insurance testing,
                                                                                and does not include
                                                                                test systems intended
                                                                                for Federal drug
                                                                                testing programs
                                                                                (e.g., programs run
                                                                                by the Substance
                                                                                Abuse and Mental
                                                                                Health Services
                                                                                Administration
                                                                                (SAMHSA), the
                                                                                Department of
                                                                                Transportation (DOT),
                                                                                and the U.S.
                                                                                military.)
862.3250.......................  Thin Layer         PVA..............  DMN..............  Exemption is limited
                                  Chromatography,                                          to test systems
                                  Cocaine.                                                 intended for
                                                                                employment and
                                                                                insurance testing
                                                                                that include a
                                                                                statement in their
                                                                                labeling that the
                                                                                device is intended
                                                                                solely for use in
                                                                                employment and
                                                                                insurance testing,
                                                                                and does not include
                                                                                test systems intended
                                                                                for Federal drug
                                                                                testing programs
                                                                                (e.g., programs run
                                                                                by the Substance
                                                                                Abuse and Mental
                                                                                Health Services
                                                                                Administration
                                                                                (SAMHSA), the
                                                                                Department of
                                                                                Transportation (DOT),
                                                                                and the U.S.
                                                                                military.)

862.3250.......................  Free Radical       PVA..............  DIR..............  Exemption is limited
                                  Assay, Cocaine.                                          to test systems
                                                                                intended for
                                                                                employment and
                                                                                insurance testing
                                                                                that include a
                                                                                statement in their
                                                                                labeling that the
                                                                                device is intended
                                                                                solely for use in
                                                                                employment and
                                                                                insurance testing,
                                                                                and does not include
                                                                                test systems intended
                                                                                for Federal drug
                                                                                testing programs
                                                                                (e.g., programs run
                                                                                by the Substance
                                                                                Abuse and Mental
                                                                                Health Services
                                                                                Administration
                                                                                (SAMHSA), the
                                                                                Department of
                                                                                Transportation (DOT),
                                                                                and the U.S.
                                                                                military.)
862.3250.......................  Gas                PVA..............  DIN..............  Exemption is limited
                                  Chromatography,                                          to test systems
                                  Cocaine.                                                 intended for
                                                                                employment and
                                                                                insurance testing
                                                                                that include a
                                                                                statement in their
                                                                                labeling that the
                                                                                device is intended
                                                                                solely for use in
                                                                                employment and
                                                                                insurance testing,
                                                                                and does not include
                                                                                test systems intended
                                                                                for Federal drug
                                                                                testing programs
                                                                                (e.g., programs run
                                                                                by the Substance
                                                                                Abuse and Mental
                                                                                Health Services
                                                                                Administration
                                                                                (SAMHSA), the
                                                                                Department of
                                                                                Transportation (DOT),
                                                                                and the U.S.
                                                                                military.)
862.3250.......................  Thin Layer         PVA..............  DOM..............  Exemption is limited
                                  Chromatography,                                          to test systems
                                  Benzoylecgonine.                                         intended for
                                                                                employment and
                                                                                insurance testing
                                                                                that include a
                                                                                statement in their
                                                                                labeling that the
                                                                                device is intended
                                                                                solely for use in
                                                                                employment and
                                                                                insurance testing,
                                                                                and does not include
                                                                                test systems intended
                                                                                for Federal drug
                                                                                testing programs
                                                                                (e.g., programs run
                                                                                by the Substance
                                                                                Abuse and Mental
                                                                                Health Services
                                                                                Administration
                                                                                (SAMHSA), the
                                                                                Department of
                                                                                Transportation (DOT),
                                                                                and the U.S.
                                                                                military.)
862.3250.......................  High Pressure      PVA..............  LAC..............  Exemption is limited
                                  Liquid                                                   to test systems
                                  Chromatography,                                          intended for
                                  Cocaine and                                              employment and
                                  Cocaine                                                  insurance testing
                                  Metabolites.                                             that include a
                                                                                statement in their
                                                                                labeling that the
                                                                                device is intended
                                                                                solely for use in
                                                                                employment and
                                                                                insurance testing,
                                                                                and does not include
                                                                                test systems intended
                                                                                for Federal drug
                                                                                testing programs
                                                                                (e.g., programs run
                                                                                by the Substance
                                                                                Abuse and Mental
                                                                                Health Services
                                                                                Administration
                                                                                (SAMHSA), the
                                                                                Department of
                                                                                Transportation (DOT),
                                                                                and the U.S.
                                                                                military.)
862.3270.......................  High Pressure      PVB..............  LAE..............  Exemption is limited
                                  Liquid                                                   to test systems
                                  Chromatography,                                          intended for
                                  Codeine.                                                 employment and
                                                                                insurance testing
                                                                                that include a
                                                                                statement in their
                                                                                labeling that the
                                                                                device is intended
                                                                                solely for use in
                                                                                employment and
                                                                                insurance testing,
                                                                                and does not include
                                                                                test systems intended
                                                                                for Federal drug
                                                                                testing programs
                                                                                (e.g., programs run
                                                                                by the Substance
                                                                                Abuse and Mental
                                                                                Health Services
                                                                                Administration
                                                                                (SAMHSA), the
                                                                                Department of
                                                                                Transportation (DOT),
                                                                                and the U.S.
                                                                                military.)
862.3270.......................  Thin Layer         PVB..............  DLD..............  Exemption is limited
                                  Chromatography,                                          to test systems
                                  Codeine.                                                 intended for
                                                                                employment and
                                                                                insurance testing
                                                                                that include a
                                                                                statement in their
                                                                                labeling that the
                                                                                device is intended
                                                                                solely for use in
                                                                                employment and
                                                                                insurance testing,
                                                                                and does not include
                                                                                test systems intended
                                                                                for Federal drug
                                                                                testing programs
                                                                                (e.g., programs run
                                                                                by the Substance
                                                                                Abuse and Mental
                                                                                Health Services
                                                                                Administration
                                                                                (SAMHSA), the
                                                                                Department of
                                                                                Transportation (DOT),
                                                                                and the U.S.
                                                                                military.)
862.3270.......................  Gas                PVB..............  LAD..............  Exemption is limited
                                  Chromatography,                                          to test systems
                                  Codeine.                                                 intended for
                                                                                employment and
                                                                                insurance testing
                                                                                that include a
                                                                                statement in their
                                                                                labeling that the
                                                                                device is intended
                                                                                solely for use in
                                                                                employment and
                                                                                insurance testing,
                                                                                and does not include
                                                                                test systems intended
                                                                                for Federal drug
                                                                                testing programs
                                                                                (e.g., programs run
                                                                                by the Substance
                                                                                Abuse and Mental
                                                                                Health Services
                                                                                Administration
                                                                                (SAMHSA), the
                                                                                Department of
                                                                                Transportation (DOT),
                                                                                and the U.S.
                                                                                military.)
862.3580.......................  Radioimmunoassay,  PVC..............  DLB..............  Exemption is limited
                                  LSD (125-I).                                             to test systems
                                                                                intended for
                                                                                employment and
                                                                                insurance testing
                                                                                that include a
                                                                                statement in their
                                                                                labeling that the
                                                                                device is intended
                                                                                solely for use in
                                                                                employment and
                                                                                insurance testing,
                                                                                and does not include
                                                                                test systems intended
                                                                                for Federal drug
                                                                                testing programs
                                                                                (e.g., programs run
                                                                                by the Substance
                                                                                Abuse and Mental
                                                                                Health Services
                                                                                Administration
                                                                                (SAMHSA), the
                                                                                Department of
                                                                                Transportation (DOT),
                                                                                and the U.S.
                                                                                military.)

862.3580.......................  Free Radical       PVC..............  DOL..............  Exemption is limited
                                  Assay, LSD.                                              to test systems
                                                                                intended for
                                                                                employment and
                                                                                insurance testing
                                                                                that include a
                                                                                statement in their
                                                                                labeling that the
                                                                                device is intended
                                                                                solely for use in
                                                                                employment and
                                                                                insurance testing,
                                                                                and does not include
                                                                                test systems intended
                                                                                for Federal drug
                                                                                testing programs
                                                                                (e.g., programs run
                                                                                by the Substance
                                                                                Abuse and Mental
                                                                                Health Services
                                                                                Administration
                                                                                (SAMHSA), the
                                                                                Department of
                                                                                Transportation (DOT),
                                                                                and the U.S.
                                                                                military.)
862.3610.......................  Gas                PVD..............  LAF..............  Exemption is limited
                                  Chromatography,                                          to test systems
                                  Methamphetamine.                                         intended for
                                                                                employment and
                                                                                insurance testing
                                                                                that include a
                                                                                statement in their
                                                                                labeling that the
                                                                                device is intended
                                                                                solely for use in
                                                                                employment and
                                                                                insurance testing,
                                                                                and does not include
                                                                                test systems intended
                                                                                for Federal drug
                                                                                testing programs
                                                                                (e.g., programs run
                                                                                by the Substance
                                                                                Abuse and Mental
                                                                                Health Services
                                                                                Administration
                                                                                (SAMHSA), the
                                                                                Department of
                                                                                Transportation (DOT),
                                                                                and the U.S.
                                                                                military.)
862.3610.......................  Thin Layer         PVD..............  DJC..............  Exemption is limited
                                  Chromatography,                                          to test systems
                                  Methamphetamine.                                         intended for
                                                                                employment and
                                                                                insurance testing
                                                                                that include a
                                                                                statement in their
                                                                                labeling that the
                                                                                device is intended
                                                                                solely for use in
                                                                                employment and
                                                                                insurance testing,
                                                                                and does not include
                                                                                test systems intended
                                                                                for Federal drug
                                                                                testing programs
                                                                                (e.g., programs run
                                                                                by the Substance