21 CFR § 807.97 - Misbranding by reference to premarket notification.

---
identifier: "/us/cfr/t21/s807.97"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 807.97 - Misbranding by reference to premarket notification."
title_number: 21
title_name: "Food and Drugs"
section_number: "807.97"
section_name: "Misbranding by reference to premarket notification."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "807"
part_name: "ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321, 331, 351, 352, 360, 360c, 360e, 360e-4, 360i, 360j, 360bbb-8b, 371, 374, 379k-1, 381, 393; 42 U.S.C. 264, 271."
regulatory_source: "42 FR 42526, Aug. 23, 1977, unless otherwise noted."
cfr_part: "807"
---


# 807.97 Misbranding by reference to premarket notification.

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.