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: 21CFR882.5893]

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. 882.5893 Thermal vestibular stimulator for headache.

(a) Identification. The thermal vestibular stimulator for headache is a prescription device used to stimulate the vestibular system by applying thermal waveforms through earpieces placed in a patient's ear canal for the treatment of headache.

(b) 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.

(2) Performance testing must validate electromagnetic compatibility and electrical, mechanical, and thermal safety.

(3) The technical parameters of the device, including waveform outputs and temperature limits, must be identified.

(4) Cleaning validation of earpieces must be conducted.

(5) Software verification, validation, and hazard analysis must be performed.

(6) Labeling must include the following:

(i) Information on how the device operates and the typical sensations experienced during treatment;

(ii) A detailed summary of the device's technical parameters; and

(iii) Instructions for maintenance and cleaning of the device.

[83 FR 52973, Oct. 19, 2018]