21 CFR 876.5270
§ 876.5270 Implanted electrical urinary continence device.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 876.5270, § 876.5270 Implanted electrical urinary continence device, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90335
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Full text
(a) Identification. An implanted electrical urinary device is a device intended for treatment of urinary incontinence that consists of a receiver implanted in the abdomen with electrodes for pulsed-stimulation that are implanted either in the bladder wall or in the pelvic floor, and a battery-powered transmitter outside the body.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any implanted electrical urinary continence device that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to an implanted electrical urinary continence device that was in commercial distribution before May 28, 1976. Any other implanted electrical urinary continence device shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.