21 CFR 812.7
Prohibition of promotion and other practices
21 CFR 812.7 is the regulation titled “Prohibition of promotion and other practices” in 21 CFR Part 812, Investigational Device Exemptions. Since 2021, 1 FDA warning letter has cited it.
- Letters citing it
- 1 since 2021
- Jan 1 to Oct 30, 2026
- 1 against 0 on the same dates in 2025
- Most often cited with
- 21 CFR 807.81, in 1 letter
- Closed out
- 0% 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
- 02023
- 02024
- 02025
- 12026
The regulation
Read the text of 21 CFR 812.7 (eCFR, as of Sep 1, 2026)
A sponsor, investigator, or any person acting for or on behalf of a sponsor or investigator shall not:
(a) Promote or test market an investigational device, until after FDA has approved the device for commercial distribution.
(b) Commercialize an investigational device by charging the subjects or investigators for a device a price larger than that necessary to recover costs of manufacture, research, development, and handling.
(c) Unduly prolong an investigation. If data developed by the investigation indicate in the case of a class III device that premarket approval cannot be justified or in the case of a class II device that it will not comply with an applicable performance standard or an amendment to that standard, the sponsor shall promptly terminate the investigation.
(d) Represent that an investigational device is safe or effective for the purposes for which it is being investigated.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 812.7.
- 21 CFR 807.81When a premarket notification submission is required1 letter cites both
- 21 CFR 812.35Supplemental applications1 letter cites both
- 21 CFR 812.40General responsibilities of sponsors1 letter cites both
- 21 CFR 812.46Monitoring investigations1 letter cites both
- 21 CFR 812.5Labeling of investigational devices1 letter cites both
Latest letters citing it
The letter citing 21 CFR 812.7 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.