[Federal Register Volume 82, Number 144 (Friday, July 28, 2017)]
[Rules and Regulations]
[Pages 35067-35069]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-15894]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 876

[Docket No. FDA-2017-N-1609]


Medical Devices; Gastroenterology-Urology Devices; Classification 
of the Oral Removable Palatal Space Occupying Device for Weight 
Management and/or Weight Loss

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is 
classifying the oral removable palatal space occupying device for 
weight management and/or weight loss into class II (special controls). 
The special controls that will apply to the device are identified in 
this order and will be part of the codified language for the oral 
removable palatal space occupying device for weight management and/or 
weight loss classification. The Agency is classifying the device into 
class II (special controls) in order to provide a reasonable assurance 
of safety and effectiveness of the device.

DATES: This order is effective July 28, 2017. The classification was 
applicable on September 26, 2016.

FOR FURTHER INFORMATION CONTACT: Mark Antonino, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. G208, Silver Spring, MD, 20993-0002, 240-402-9980, 
[email protected].

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

[[Page 35068]]

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, also known as De Novo 
classification, as amended by section 607 of the Food and Drug 
Administration Safety and Innovation Act (Pub. L. 112-144), provides 
two procedures by which a person may request FDA to classify a device 
under the criteria set forth in section 513(a)(1) of the FD&C Act. 
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), the 
person requests a classification under section 513(f)(2) of the FD&C 
Act. Under the second procedure, rather than first submitting a 
premarket notification under section 510(k) of the FD&C Act 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 shall 
classify the device by written order within 120 days. This 
classification will be the initial classification of the device.
    On July 31, 2015, Scientific Intake submitted a request for 
classification of the Sensor Monitored Alimentary Restriction Therapy 
(SMART) device under section 513(f)(2) of the FD&C Act.
    In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed 
the request in order to classify the device under the criteria for 
classification set forth in section 513(a)(1). 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, in addition to general controls, will provide reasonable 
assurance of the safety and effectiveness of the device.
    Therefore, on September 26, 2016, FDA issued an order to the 
requestor classifying the device into class II. FDA is codifying the 
classification of the device by adding 21 CFR 876.5981.
    Following the effective date of this final classification order, 
any firm submitting a premarket notification (510(k)) for an oral 
removable palatal space occupying device for weight management and/or 
weight loss will need to comply with the special controls named in this 
final order. A De Novo classification decreases regulatory burdens. 
When FDA classifies a device type as class I or II via the De Novo 
pathway, other manufacturers do not have to submit a De Novo request or 
premarket approval application to market the same type of device, 
unless the device has a new intended use or technological 
characteristics that raise different questions of safety or 
effectiveness. Instead, manufacturers can use the less burdensome 
510(k) pathway, when necessary, to market their device, and the device 
that was the subject of the original De Novo classification can serve 
as a predicate device for additional 510(k)s from other manufacturers.
    The device is assigned the generic name oral removable palatal 
space occupying device for weight management and/or weight loss, and it 
is identified as a prescription device that is worn during meals to 
limit bite size, thereby reducing the amount of food that is consumed. 
The device may contain recording sensors for monitoring patient use. 
This classification does not include devices that are intended to treat 
any dental diseases or conditions.
    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--Oral Removable Palatal Space Occupying Device for Weight
  Management and/or Weight Loss Risks to Health and Mitigation Measures
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       Identified risks                   Mitigation measures
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Tooth Movement, Irritation,    Non-clinical performance testing.
 and Soreness of Mouth or      Labeling.
 Gums, including:              Training.
 Improper mold
 making;
 User error; and
 Damage to material
 (soft edge separation)
Choking or gag reflex........  Clinical performance testing.
                               Labeling.
Adverse tissue reaction......  Biocompatibility evaluation.
Incorrect data                 Non-clinical performance testing.
 interpretation, including:    Labeling.
 Hardware malfunction  Training.
 (sensor malfunction)
Electrical shock and           Non-clinical performance testing.
 electrical interference with
 other devices.
Weight gain..................  Clinical performance testing.
                               Labeling.
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    FDA believes that the special controls, in combination with the 
general controls, address these risks to health and provide reasonable 
assurance of safety and effectiveness.
    Oral removable palatal space occupying devices for weight 
management and/or weight loss are not safe for use except under the 
supervision of a practitioner licensed by law to direct the use of the 
device. As such, the device is a prescription device and must satisfy 
prescription labeling requirements (see 21 CFR 801.109, Prescription 
devices).

[[Page 35069]]

    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), 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 believes premarket notification is 
not necessary to provide reasonable assurance of the safety and 
effectiveness of the device type and, therefore, is planning to exempt 
the device from the premarket notification requirements under section 
510(m) of the FD&C Act. Once finalized, persons who intend to market 
this device type need not submit a 510(k) premarket notification 
containing information on the oral removable palatal space occupying 
device for weight management and/or weight loss prior to marketing the 
device.

II. 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.

III. Paperwork Reduction Act of 1995

    This final 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, and the collections 
of information in 21 CFR part 801 regarding labeling have been approved 
under OMB control number 0910-0485.

List of Subjects in 21 CFR Part 876

    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 
876 is amended as follows:

PART 876--GASTROENTEROLOGY-UROLOGY DEVICES

0
1. The authority citation for part 876 continues to read as follows:

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


0
2. Add Sec.  876.5981 to subpart F to read as follows:


Sec.  876.5981  Oral removable palatal space occupying device for 
weight management and/or weight loss.

    (a) Identification. An oral removable palatal space occupying 
device for weight management and/or weight loss is a prescription 
device that is worn during meals to limit bite size, thereby reducing 
the amount of food that is consumed. The device may contain recording 
sensors for monitoring patient use. This classification does not 
include devices that are intended to treat any dental diseases or 
conditions
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The patient-contacting components of the device must be 
demonstrated to be biocompatible for its intended use.
    (2) Non-clinical performance testing must demonstrate that the 
device performs as intended under anticipated conditions for use, as 
follows:
    (i) Mechanical testing must demonstrate that the device performs as 
intended for the labeled use life and does not create forces that 
result in movement of teeth and damage to teeth.
    (ii) Electrical safety and electromagnetic compatibility testing 
must demonstrate that the device performs as intended.
    (iii) Software verification and validation must demonstrate that 
the device performs as intended.
    (iv) Battery testing must demonstrate that the device battery 
performs as intended.
    (3) Clinical performance testing must demonstrate the device 
performs as intended and must include an evaluation for choking.
    (4) Device labeling must address the following:
    (i) Patient labeling must state:
    (A) The clinical benefit of weight management and/or weight loss as 
assessed by using percent total body weight loss;
    (B) Treatment must be offered in combination with a behavioral 
modification program;
    (C) Instructions on how to use the device as intended; and
    (D) The use life of the device.
    (ii) Physician labeling must state:
    (A) The clinical benefit of weight management and/or weight loss as 
assessed by using percent total body weight loss;
    (B) Treatment must be offered in combination with a behavioral 
modification program;
    (C) Instructions on how to use the device as intended; and
    (D) The use life of the device.
    (5) Training must be provided to health professionals that includes 
procedures for determining a patient's oral health status, instructions 
for making the palatal mold, and assessment of issues with the device 
that may require service by the manufacturer.

    Dated: July 24, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-15894 Filed 7-27-17; 8:45 am]
 BILLING CODE 4164-01-P