21 CFR 870.3545
§ 870.3545 Ventricular bypass (assist) device.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 870.3545, § 870.3545 Ventricular bypass (assist) device, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89963
- Permanent ID
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Full text
(a) Identification. A ventricular bypass (assist) device is a device that assists the left or right ventricle in maintaining circulatory blood flow. The device is either totally or partially implanted in the body.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before November 21, 2011, for any ventricular bypass (assist) device that was in commercial distribution before May 28, 1976, or that has, on or before November 21, 2011, been found to be substantially equivalent to any ventricular bypass (assist) device that was in commercial distribution before May 28, 1976. Any other ventricular bypass (assist) device shall have an approved PMA or 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.