CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

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

[Code of Federal Regulations]

[Title 21, Volume 8]

[CITE: 21CFR882.5060]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER H - MEDICAL DEVICES

PART 882 -- NEUROLOGICAL DEVICES

Subpart F - Neurological Therapeutic Devices

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.

[86 FR 68403, Dec. 2, 2021]