---
kind: "section"
citation: "21 C.F.R. § 812.7"
title: "21"
number: "812.7"
heading: "Prohibition of promotion and other practices."
url: "https://uscodex.org/cfr/21/812.7"
---

# §812.7. Prohibition of promotion and other practices.


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.

## Notes

### Authority

Authority: 21 U.S.C. 331, 351, 352, 353, 355, 360, 360c-360f, 360h-360j, 360hh-360pp, 360rr-360ss, 360bbb-8b, 371, 372, 374, 379e, 381, 382; 42 U.S.C. 216, 241, 262.

### Source

Source: 45 FR 3751, Jan. 18, 1980, unless otherwise noted.