Yes, the IDE regulation prohibits certain conduct by sponsors and investigators pertaining to the investigation and distribution of investigational devices, among other practices. These activities include (see 21 CFR 812.7):
- Promote or test market an investigational device, until after FDA has approved the device for commercial distribution.
- 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.
- 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.
- Represent that an investigational device is safe or effective for the purposes for which it is being investigated.
