Document ID: FDA-2017-N-1609-0002
Agency: fda
Document Type: Rule
Title: Medical Devices; Gastroenterology-Urology Devices; Classification of the Oral Removable Palatal Space Occupying Device for Weight Management and/or Weight Loss
Posted Date: 2017-10-30T04:00Z

[Federal Register Volume 82, Number 208 (Monday, October 30, 2017)]
[Rules and Regulations]
[Page 50080]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-23490]

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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; correction.

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SUMMARY: The Food and Drug Administration (FDA) is correcting a final 
order entitled ``Medical Devices; Gastroenterology-Urology Devices; 
Classification of the Oral Removable Palatal Space Occupying Device for 
Weight Management and/or Weight Loss'' that appeared in the Federal 
Register of July 28, 2017. The final order was published with an 
incorrect statement in the preamble about whether FDA planned to exempt 
the device from premarket notification requirements. This document 
corrects that error.

DATES: Effective October 30, 2017

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: In the Federal Register of July 28, 2017 (82 
FR 35067), FDA published the final order ``Medical Devices; 
Gastroenterology-Urology Devices; Classification of the Oral Removable 
Palatal Space Occupying Device for Weight Management and/or Weight 
Loss.'' The final order published with an incorrect statement in the 
preamble about whether FDA planned to exempt the device from premarket 
notification requirements under section 510(k) of the FD&C Act.
    In the Federal Register of July 28, 2017, (82 FR 35067), the 
following correction is made: On page 35069, in the first column, the 
first paragraph is corrected as follows:
    ``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 has 
determined that premarket notification is necessary to provide 
reasonable assurance of the safety and effectiveness of the device. 
Therefore, this device type 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 oral removable palatal space 
occupying device for weight management and/or weight loss they intend 
to market.''

    Dated: October 24, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-23490 Filed 10-27-17; 8:45 am]
 BILLING CODE 4164-01-P