[Federal Register Volume 79, Number 175 (Wednesday, September 10, 2014)]
[Rules and Regulations]
[Pages 53608-53609]
[FR Doc No: 2014-21479]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 866

[Docket No. FDA-2014-N-1166]

Medical Devices; Immunology and Microbiology Devices;
Classification of Dengue Virus Nucleic Acid Amplification Test Reagents

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA) is classifying dengue
virus nucleic acid amplification test reagents into class II (special
controls). The Agency is classifying the device into class II (special
controls) because special controls, in addition to general controls,
will provide a reasonable assurance of safety and effectiveness of the
device.

DATES: This order is effective October 10, 2014. The classification was
applicable May 24, 2012.

FOR FURTHER INFORMATION CONTACT: Beena Puri, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5553, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In accordance with section 513(f)(1) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were
not in commercial distribution before May 28, 1976 (the date of
enactment of the Medical Device Amendments of 1976), generally referred
to as postamendments devices, are classified automatically by statute
into class III without any FDA rulemaking process. These devices remain
in class III and require premarket approval, unless and until the
device is classified or reclassified into class I or II, or FDA issues
an order finding the device to be substantially equivalent, in
accordance with section 513(i) of the FD&C Act, to a predicate device
that does not require premarket approval. The Agency determines whether
new devices are substantially equivalent to predicate devices by means
of premarket notification procedures in section 510(k) of the FD&C Act
(21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations.
    Section 513(f)(2) of the FD&C Act, as amended by section 607 of the
Food and Drug Administration Safety and Innovation Act (Pub. L. 112-
144, July 9, 2012, 126 Statute 1054), provides two procedures by which
a person may request FDA to classify a device under the criteria set
forth in section 513(a)(1). Under the first procedure, the person
submits a premarket notification under section 510(k) of the FD&C Act
for a device that has not previously been classified and, within 30
days of receiving an order classifying the device into class III under
section 513(f)(1) of the FD&C Act, the person requests a classification
under section 513(f)(2). Under the second procedure, rather than first
submitting a premarket notification under section 510(k) and then a
request for classification under the first procedure, the person
determines that there is no legally marketed device upon which to base
a determination of substantial equivalence and requests a
classification under section 513(f)(2) of the FD&C Act. If the person
submits a request to classify the device under this second procedure,
FDA may decline to undertake the classification request if FDA
identifies a legally marketed device that could provide a reasonable
basis for review of substantial equivalence with the device or if FDA
determines that the device submitted is not of ``low-moderate risk'' or
that general controls would be inadequate to control the risks and
special controls to mitigate the risks cannot be developed.
    In response to a request to classify a device under either
procedure provided by section 513(f)(2) of the FD&C Act, FDA will
classify the device by written order within 120 days. This
classification will be the initial classification of the device. Within
30 days after the issuance of an order classifying the device, FDA must
publish a notice in the Federal Register announcing this
classification.
    In accordance with section 513(f)(1) of the FD&C Act, FDA issued an
order on February 24, 2012, classifying the CDC DENV-1-4 Real-Time RT-
PCR Assay into class III, because it was not substantially equivalent
to a device that was introduced or delivered for introduction into
interstate commerce for commercial distribution before May 28, 1976, or
a device which was subsequently reclassified into class I or class II.
On March 12, 2012, the Centers for Disease Control and Prevention
submitted a request for de novo classification of the CDC DENV-1-4
Real-Time RT-PCR Assay under section 513(f)(2) of the FD&C Act. The
manufacturer recommended that the device be classified into class II.
    In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed
the request for de novo classification in order to classify the device
under the criteria for classification set forth in section 513(a)(1) of
the FD&C Act. FDA classifies devices into class II if general controls
by themselves are insufficient to provide reasonable assurance of
safety and effectiveness, but there is sufficient information to
establish special controls to provide reasonable assurance of the
safety and effectiveness of the device for its intended use. After
review of the information submitted in the request, FDA determined that
the device can be classified into class II with the establishment of
special controls. FDA believes these special controls will provide
reasonable assurance of the safety and effectiveness of the device.
    The device is assigned the generic name dengue virus nucleic acid
amplification test reagents, and it is identified as devices that
consist of primers, probes, enzymes, and controls for the amplification
and detection of dengue virus serotypes 1, 2, 3, or 4 from viral
ribonucleic acid (RNA) in human serum and plasma from individuals who
have signs and symptoms consistent with dengue (mild or severe). The
identification of dengue virus serotypes 1, 2, 3, or 4 in human serum
and plasma (sodium citrate) collected from human

patients with dengue provides epidemiologic information for
surveillance of circulating dengue viruses.
    FDA has identified the following risks to health associated with
this type of device and the measures required to mitigate these risks:

       Table 1--Identified Risks to Health and Mitigation Measures
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       Identified risks to health              Mitigation measures
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A false positive test result for an      Device description containing
 individual may lead to unnecessary       the information specified in
 treatment and possibly a less thorough   the special control guideline.
 laboratory evaluation for the true      Performance characteristics.
 cause of illness; a false positive      Labeling.
 result may lead to unnecessary          Postmarket measures.
 initiation of mosquito vector control
 measures.
A false negative test result may lead    Device description containing
 to inappropriate use of antibiotics or   the information specified in
 a delay in treatment to prevent death    the special control guideline.
 due to dengue hemorrhagic fever or      Performance characteristics.
 dengue shock syndrome or a false        Labeling.
 negative result may lead to delay in    Postmarket measures.
 initiation of mosquito vector control
 measures.
An error in the interpretation of the    Labeling.
 results.
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    FDA believes that the measures set forth in the special controls
guideline entitled ``Class II Special Controls Guideline: Dengue Virus
Nucleic Acid Amplification Test Reagents'' are necessary, in addition
to general controls, to mitigate the risks to health described in table
1.
    Therefore, on May 24, 2012, FDA issued an order to the petitioner
classifying dengue virus nucleic acid amplification test reagents into
class II. FDA is codifying this device type by adding Sec.  866.3946.

II. 510(k) Premarket Notification

    Following the effective date of this final classification order,
any firm submitting a 510(k) premarket notification for this device
type will need to comply with the special controls.
    Section 510(m) of the FD&C Act provides that FDA may exempt a class
II device from the premarket notification requirements under section
510(k) of the FD&C Act if FDA determines that premarket notification is
not necessary to provide reasonable assurance of the safety and
effectiveness of the device. For this type of device, FDA has
determined that premarket notification is necessary to provide
reasonable assurance of the safety and effectiveness of the device.
Therefore, this type of device is not exempt from premarket
notification requirements. Persons who intend to market this type of
device must submit to FDA a premarket notification, prior to marketing
the device, which contains information about the dengue virus nucleic
acid amplification test reagents they intend to market.

III. Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is
of type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

IV. Paperwork Reduction Act of 1995

    This final administrative order establishes special controls that
refer to previously approved collections of information found in other
FDA regulations. These collections of information are subject to review
by the Office of Management and Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of
information in part 807, subpart E, regarding premarket notification
submissions have been approved under OMB control number 0910-0120; the
collections of information in 21 CFR part 820 have been approved under
OMB control number 0910-0073; and the collections of information in 21
CFR part 801 and 21 CFR 809.10 have been approved under OMB control
number 0910-0485.

List of Subjects in 21 CFR Part 866

    Biologics, Laboratories, Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
866 is amended as follows:

PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES

0
1. The authority citation for 21 CFR part 866 continues to read as
follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

0
2. Section 866.3946 is added to subpart D to read as follows:

Sec.  866.3946  Dengue virus nucleic acid amplification test reagents.

    (a) Identification. Dengue virus nucleic acid amplification test
reagents are devices that consist of primers, probes, enzymes, and
controls for the amplification and detection of dengue virus serotypes
1, 2, 3, or 4 from viral ribonucleic acid (RNA) in human serum and
plasma from individuals who have signs and symptoms consistent with
dengue (mild or severe). The identification of dengue virus serotypes
1, 2, 3, or 4 in human serum and plasma (sodium citrate) collected from
human patients with dengue provides epidemiologic information for
surveillance of circulating dengue viruses.
    (b) Classification. Class II (special controls). The special
control is FDA's guideline entitled ``Class II Special Controls
Guideline: Dengue Virus Nucleic Acid Amplification Test Reagents.'' For
availability of the guideline document, see Sec.  866.1(e).

    Dated: September 4, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-21479 Filed 9-9-14; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: August 28, 2008 (Volume 73, Number 168)]
[Rules and Regulations]
[Page 50721]
[DOCID:fr28au08-10]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2008-0170; Airspace Docket No. 08-AEA-16]

Modification of Class E Airspace; Staunton, VA

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule, confirmation of effective date.

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SUMMARY: This action confirms the effective date of a direct final rule
published in the Federal Register (73 FR 16751) that modifies the
effective time of the Class E Airspace at Staunton, VA. The Shenandoah
Valley Regional Airport Commission has requested to change their
current Class E2 Airspace from part time (currently 1200 to 0400 Zulu)
to full time. This action enhances the safety and management of
Instrument Flight Rule (IFR) operations in the area by providing the
required controlled airspace to support terminal operations
continuously at Staunton, VA.

DATES: 0901 UTC, Effective June 5, 2008. The Director of the Federal
Register approves this incorporation by reference action under title 1,
Code of Federal Regulations, part 51, subject to the annual revision of
FAA Order 7400.9 and publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: Melinda Giddens, Operations Support
Group, Federal Aviation Administration, P.O. Box 20636, Atlanta,
Georgia 30320; Telephone<PHONE_NUMBER>, Fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

The Confirmation of Effective Date

    The FAA published this direct final rule with a request for
comments in the Federal Register on March 31, 2008 (73 FR 16751),
Docket No. FAA 2008-0170; Airspace Docket No. 08-AEA-16. The FAA uses
the direct final rulemaking procedure for a non-controversial rule
where the FAA believes that there will be no adverse public comment.
This direct final rule advised the public that no adverse comments were
anticipated, and that unless a written adverse comment, or a written
notice of intent to submit such an adverse comment, were received
within the comment period, the regulation would become effective on
June 5, 2008. No adverse comments were received, and thus this notice
confirms that effective date.

    Issued in College Park, Georgia, on July 16, 2008.
Mark D. Ward,
Manager, Operations Support Group, Eastern Service Center, Air Traffic
Organization.
[FR Doc. E8-19277 Filed 8-27-08; 8:45 am]

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