21 CFR § 882.5050 - Biofeedback device.

---
identifier: "/us/cfr/t21/s882.5050"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 882.5050 - Biofeedback device."
title_number: 21
title_name: "Food and Drugs"
section_number: "882.5050"
section_name: "Biofeedback device."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "882"
part_name: "NEUROLOGICAL DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "44 FR 51730, Sept. 4, 1979, unless otherwise noted."
cfr_part: "882"
---


# 882.5050 Biofeedback device.

(a) *Identification.* A biofeedback device is an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient's physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters.

(b) *Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter when it is a prescription battery powered device that is indicated for relaxation training and muscle reeducation and prescription use, subject to § 882.9.

[44 FR 51730, Sept. 4, 1979, as amended at 63 FR 59229, Nov. 3, 1998]