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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of Nov 29, 2022.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[CITE: 21CFR876.5982]
See Related Information on Ingested, transient, space occupying device for weight management and/or weight loss. in CDRH databases



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H - MEDICAL DEVICES

PART 876 -- GASTROENTEROLOGY-UROLOGY DEVICES

Subpart F - Therapeutic Devices

Sec. 876.5982 Ingested, transient, space occupying device for weight management and/or weight loss.

(a) Identification. This device is an ingested material that transiently occupies space in the stomach. The device passes from the body via the natural gastrointestinal tract.

(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) Performance bench testing in a simulated use model must evaluate device disintegration and device hydration state throughout the gastrointestinal tract;

(ii) Bioburden and moisture content assessments must evaluate device infection risk throughout the labeled shelf life; and

(iii) Performance data must support the shelf life of the device by demonstrating continued package integrity and device functionality over the labeled shelf life.

(3) Clinical performance testing must demonstrate the device performs as intended and evaluate the following:

(i) Weight change;

(ii) All adverse events, including obstruction, dilation, diarrhea, constipation, and dehydration; and

(iii) Interaction with representative medications.

(4) Physician and patient device labeling must state:

(i) The clinical benefit of the device as assessed by using percent total body weight loss;

(ii) Treatment must be offered in combination with diet and exercise;

(iii) Instructions on how to use the device as intended including how to avoid interaction with medication; and

(iv) The shelf life of the device.

[86 FR 70372, Dec. 10, 2021]

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