• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

  • Print
  • Share
  • E-mail
-

The information on this page is current as of April 1 2019.

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

New Search
Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2019]
[CITE: 21CFR882.5892]
See Related Information on External vagal nerve stimulator for headache. in CDRH databases



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. 882.5892 External vagal nerve stimulator for headache.

(a) Identification. An external vagal nerve stimulator for headache is a prescription device used to apply an electrical current to a patient's vagus nerve through electrodes placed on the skin for the treatment of headache.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) The technical parameters of the device, including waveform, output modes, maximum output voltage and current (with 500, 2,000, and 10,000 ohm loads), pulse duration, frequency, net charge ([micro]C) per pulse, maximum phase charge at 500 ohms, maximum current density (mA/cm 2, r.m.s.), maximum average current (mA), maximum average power density (W/cm 2), and the type of impedance monitoring system shall be fully characterized through non-clinical performance testing.

(2) Software verification, validation, and hazard analysis shall be performed.

(3) Biocompatibility evaluation of the patient-contacting components of the device shall be performed.

(4) The device shall be tested for electrical, thermal, and mechanical safety, and for electromagnetic compatibility (EMC).

(5) The labeling must include:

(i) Instructions for proper use of the device, including placement of the device on the patient; and

(ii) Instructions on care and cleaning of the device.

[82 FR 61169, Dec. 27, 2017]

-
-