[Federal Register Volume 86, Number 229 (Thursday, December 2, 2021)]
[Rules and Regulations]
[Pages 68401-68403]
[FR Doc No: 2021-26176]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 882

[Docket No. FDA-2021-N-0290]

Medical Devices; Neurological Devices; Classification of the
Conditioning Tool for Eating Disorders

AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).

ACTION: Final amendment; final order.

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SUMMARY: The Food and Drug Administration (FDA or we) is classifying
the conditioning tool for eating disorders into class II (special
controls). The special controls that apply to the device type are
identified in this order and will be part of the codified language for
the conditioning tool for eating disorders' classification. We are
taking this action because we

have determined that classifying the device into class II (special
controls) will provide a reasonable assurance of safety and
effectiveness of the device. We believe this action will also enhance
patients' access to beneficial innovative devices.

DATES: This order is effective December 2, 2021. The classification was
applicable on March 31, 2011.

FOR FURTHER INFORMATION CONTACT: Michael Hoffmann, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave. Bldg. 66, Rm. 4110, Silver Spring, MD 20993-0002, 301-
796-6476, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the conditioning tool for eating
disorders as class II (special controls), which we have determined will
provide a reasonable assurance of safety and effectiveness. In
addition, we believe this action will enhance patients' access to
beneficial innovation, by placing the device into a lower device class
than the automatic class III assignment.
    The automatic assignment of class III occurs by operation of law
and without any action by FDA, regardless of the level of risk posed by
the new device. Any device that was not in commercial distribution
before May 28, 1976, is automatically classified as, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device (see 21 U.S.C.
360c(f)(1)). We refer to these devices as ``postamendments devices''
because they were not in commercial distribution prior to the date of
enactment of the Medical Device Amendments of 1976, which amended the
Federal Food, Drug, and Cosmetic Act (FD&C Act).
    FDA may take a variety of actions in appropriate circumstances to
classify or reclassify a device into class I or II. We may issue an
order finding a new device to be substantially equivalent under section
513(i) of the FD&C Act to a predicate device that does not require
premarket approval (see 21 U.S.C. 360c(i)). We determine whether a new
device is substantially equivalent to a predicate by means of the
procedures for premarket notification under section 510(k) of the FD&C
Act and part 807 (21 U.S.C. 360(k) and 21 CFR part 807, respectively).
    FDA may also classify a device through ``De Novo'' classification,
a common name for the process authorized under section 513(f)(2) of the
FD&C Act (21 U.S.C. 360c(f)(2)). Section 207 of the Food and Drug
Administration Modernization Act of 1997 established the first
procedure for De Novo classification (Pub. L. 105-115). Section 607 of
the Food and Drug Administration Safety and Innovation Act modified the
De Novo application process by adding a second procedure (Pub. L. 112-
144). A device sponsor may utilize either procedure for De Novo
classification.
    Under the first procedure, the person submits a 510(k) for a device
that has not previously been classified. After receiving an order from
FDA classifying the device into class III under section 513(f)(1) of
the FD&C Act, the person then requests a classification under section
513(f)(2).
    Under the second procedure, rather than first submitting a 510(k)
and then a request for classification, if the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence, that person requests a classification under
section 513(f)(2) of the FD&C Act.
    Under either procedure for De Novo classification, FDA is required
to classify the device by written order within 120 days. The
classification will be according to the criteria under section
513(a)(1) of the FD&C Act (21 U.S.C. 360c(a)(1)). Although the device
was automatically within class III, the De Novo classification is
considered to be the initial classification of the device.
    When FDA classifies a device into class I or II via the De Novo
process, the device can serve as a predicate for future devices of that
type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a
result, other device sponsors do not have to submit a De Novo request
or premarket approval application in order to market a substantially
equivalent device (see 21 U.S.C. 360c(i), defining ``substantial
equivalence''). Instead, sponsors can use the less-burdensome 510(k)
process, when necessary, to market their device.

II. De Novo Classification

    For this device, FDA issued an order on May 24, 2007, finding the
Mandometer not substantially equivalent to a predicate not subject to
premarket approval. Thus, the device remained in class III in
accordance with section 513(f)(1) of the FD&C Act when we issued the
order.
    AB Mando submitted a request for De Novo classification of the
Mandometer, dated June 19, 2007. FDA reviewed the request in order to
classify the device under the criteria for classification set forth in
section 513(a)(1) of the FD&C Act.
    We classify 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 that, in combination with the general controls, provide
reasonable assurance of the safety and effectiveness of the device for
its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the
information submitted in the request, we determined that the device can
be classified into class II with the establishment of special controls.
FDA has determined that these special controls, in addition to the
general controls, will provide reasonable assurance of the safety and
effectiveness of the device.
    Therefore, on March 31, 2011, FDA issued an order to the requester
classifying the device into class II. In this final order, FDA is
codifying the classification of the device by adding 21 CFR
882.5060.\1\ We have named the generic type of device conditioning tool
for eating disorders, and it is identified as a prescription device
that non-invasively measures the mass of food eaten during a meal and
provides feedback in the form of eating rate, patient satiety, and
eating pattern information to the patient.
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    \1\ FDA notes that the ``ACTION'' caption for this final order
is styled as ``Final amendment; final order,'' rather than ``Final
order.'' Beginning in December 2019, this editorial change was made
to indicate that the document ``amends'' the Code of Federal
Regulations. The change was made in accordance with the Office of
Federal Register's (OFR) interpretations of the Federal Register Act
(44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and
parts 21 and 22), and the Document Drafting Handbook.
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    FDA has identified the following risks to health associated
specifically with this type of device and the measures required to
mitigate these risks in table 1.

  Table 1--Conditioning Tool for Eating Disorders Risks and Mitigation
                                Measures
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            Identified risks                   Mitigation measures
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Ineffective treatment leading to         Nonclinical performance
 worsening condition of the patient,      testing; Software validation,
 progression of disease, and/or delay     verification and hazard
 of alternative treatments.               analysis; and Labeling.
Adverse tissue reaction................  Biocompatibility evaluation.
Electrical shock or burns..............  Electrical safety testing,
                                          Electromagnetic compatibility
                                          (EMC) testing, and Labeling.
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    FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness. In order for a device to fall
within this classification, and thus avoid automatic classification in
class III, it would have to comply with the special controls named in
this final order. The necessary special controls appear in the
regulation codified by this order. This device is subject to premarket
notification requirements under section 510(k).
    At the time of classification, conditioning tools for eating
disorders are for prescription use only. Prescription devices are
exempt from the requirement for adequate directions for use for the
layperson under section 502(f)(1) of the FD&C Act and 21 CFR 801.5, as
long as the conditions of 21 CFR 801.109 are met (referring to 21
U.S.C. 352(f)(1)).

III. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is
of a 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 order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations and guidance. 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 the guidance document ``De Novo Classification
Process (Evaluation of Automatic Class III Designation)'' have been
approved under OMB control number 0910-0844; the collections of
information in part 814, subparts A through E, regarding premarket
approval, have been approved under OMB control number 0910-0231; the
collections of information in part 807, subpart E, regarding premarket
notification submissions, have been approved under OMB control number
0910-0120; and the collections of information in part 801, regarding
labeling, have been approved under OMB control number 0910-0485.

List of Subjects in 21 CFR Part 882

    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
882 is amended as follows:

PART 882--NEUROLOGICAL DEVICES

0
1. The authority citation for part 882 continues to read as follows:

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

0
2. Add Sec.  882.5060 to subpart F to read as follows:

Sec.  882.5060   Conditioning tool for eating disorders.

    (a) Identification. A conditioning tool for eating disorders is a
prescription device that non-invasively measures the mass of food eaten
during a meal and provides feedback in the form of eating rate, patient
satiety, and eating pattern information to the patient.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) Nonclinical performance testing must demonstrate:
    (i) Device measurement accuracy and repeatability; and
    (ii) Device feedback accuracy.
    (2) Software verification, validation, and hazard analysis must be
performed.
    (3) The patient-contacting components of the device must be
demonstrated to be biocompatible.
    (4) Performance testing must demonstrate the electromagnetic
compatibility (EMC) and electrical safety of the device.
    (5) Labeling and patient labeling must be provided which includes
the following:
    (i) Information identifying and explaining how to use the device
and its components; and
    (ii) Information on how the device operates and the typical course
of treatment.

    Dated: November 26, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-26176 Filed 12-1-21; 8:45 am]
BILLING CODE 4164-01-P