21 CFR 876.5982 — Ingested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss
Gastroenterology, Urology (GU) · Subpart F—Therapeutic Devices · § 876.5982
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.
Classification Rationale
Class II (special controls). The special controls for this device are:
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| QFQ | Ingested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss | 2 | 3 |
Special Controls
QFQ — Ingested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss
In combination with the general controls of the FD&C Act, the ingested, transient, space occupying device for weight management and/or weight loss is subject to the following special controls:
De Novo Order DEN180060
QFQ — Ingested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss
*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.
eCFR
QFQ — Ingested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss
(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.
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