21 CFR 807.97
§ 807.97 Misbranding by reference to premarket notification.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 807.97, § 807.97 Misbranding by reference to premarket notification, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88765
- Permanent ID
ys:prov:88765@1- SHA-256
b3ed04713ddfedf2125da50def1caa7db285bbb42da19559cd4a8a782c6f4a49
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Full text
Submission of a premarket notification in accordance with this subpart, and a subsequent determination by the Commissioner that the device intended for introduction into commercial distribution is substantially equivalent to a device in commercial distribution before May 28, 1976, or is substantially equivalent to a device introduced into commercial distribution after May 28, 1976, that has subsequently been reclassified into class I or II, does not in any way denote official approval of the device. Any representation that creates an impression of official approval of a device because of complying with the premarket notification regulations is misleading and constitutes misbranding.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.