21 CFR 882.5050
Biofeedback device
21 CFR 882.5050 is the regulation titled “Biofeedback device” in 21 CFR Part 882, Neurological Devices. Since 2021, 1 FDA warning letter has cited it.
- Letters citing it
- 1 since 2021
- Jan 1 to Oct 30, 2026
- 0 against 0 on the same dates in 2025
- Most often cited with
- 21 CFR 807.81, in 1 letter
- Closed out
- 0% of these letters have a published close-out
Letters citing it, by year issued
It is a medical device letter. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
- 02021
- 12022
- 02023
- 02024
- 02025
- 02026
The regulation
Read the text of 21 CFR 882.5050 (eCFR, as of Sep 1, 2026)
(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]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 882.5050.
- 21 CFR 807.81When a premarket notification submission is required1 letter cites both
- 21 CFR 820.100Corrective and preventive action1 letter cites both
- 21 CFR 820.198Complaint files1 letter cites both
- 21 CFR 820.20Management responsibility1 letter cites both
- 21 CFR 820.22Quality audit1 letter cites both
- 21 CFR 820.50Purchasing controls1 letter cites both
- 21 CFR 820.72Inspection, measuring, and test equipment1 letter cites both
- 21 CFR 882.1400Electroencephalograph1 letter cites both
Latest letters citing it
The letter citing 21 CFR 882.5050 that FDA posted most recently.
See the letter citing 21 CFR 882.5050 →Put this kind of reading to
work on your own records.
Botable builds and runs a custom AI layer around the software you already use, so your team can do the job you hired them for.
Counts include every citation in a letter, as the Letters filter does. How this database is built.