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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of Nov 29, 2022.

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

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[CITE: 21CFR876.5330]
See Related Information on Transcutaneous electrical continence device. 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 876 -- GASTROENTEROLOGY-UROLOGY DEVICES

Subpart F - Therapeutic Devices

Sec. 876.5330 Transcutaneous electrical continence device.

(a) Identification. A transcutaneous electrical continence device consists of cutaneous electrodes that are used to apply external stimulation to reduce urinary incontinence.

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

(1) Non-clinical performance testing must characterize the electrical stimulation, including the following: Waveforms, output modes, maximum output voltage, maximum output current, pulse duration, frequency, net charge per pulse, maximum phase charge at 500 ohms, maximum current density, maximum average current, and maximum average power density.

(2) The patient-contacting materials must be demonstrated to be biocompatible.

(3) Performance data must demonstrate the electromagnetic compatibility (EMC), electrical safety, thermal safety, and mechanical safety of the device.

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

(5) Labeling must include the following:

(i) Instructions for use, including specific instructions regarding the proper placement of electrodes;

(ii) A summary of electrical stimulation parameters; and

(iii) Cleaning instructions and reuse information.

[86 FR 73971, Dec. 29, 2021]

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