21 CFR 807.97
Misbranding by reference to premarket notification
21 CFR 807.97 is the regulation titled “Misbranding by reference to premarket notification” in 21 CFR Part 807, Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices. Since 2021, 1 FDA warning letter has cited it.
- Letters citing it
- 1 since 2021
- Jan 1 to Oct 30, 2026
- 0 against 0 on the same dates in 2025
- Most often cited with
- 21 CFR 807.81, in 1 letter
- Closed out
- 100% of these letters have a published close-out
Letters citing it, by year issued
It is a medical device letter. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
- 02021
- 02022
- 12023
- 02024
- 02025
- 02026
The regulation
Read the text of 21 CFR 807.97 (eCFR, as of Sep 1, 2026)
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.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 807.97.
- 21 CFR 807.81When a premarket notification submission is required1 letter cites both
- 21 CFR 820.184Device history record1 letter cites both
- 21 CFR 820.198Complaint files1 letter cites both
- 21 CFR 820.20Management responsibility1 letter cites both
- 21 CFR 820.25Personnel1 letter cites both
- 21 CFR 820.30Design controls1 letter cites both
- 21 CFR 820.50Purchasing controls1 letter cites both
- 21 CFR 820.70Production and process controls1 letter cites both
Latest letters citing it
The letter citing 21 CFR 807.97 that FDA posted most recently.
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Counts include every citation in a letter, as the Letters filter does. How this database is built.