21 CFR 882.5060
§ 882.5060 Conditioning tool for eating disorders.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 882.5060, § 882.5060 Conditioning tool for eating disorders, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90716
- Permanent ID
ys:prov:90716@1- SHA-256
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.