Are there activities that are prohibited by sponsors of an investigational device?

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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.

About the Author
Proxima CRO Team
Joel Reid
Regulatory Affairs Associate

Joel has a Bachelors Degree in Psychology and German. He also has undergraduate research experience in neuroimaging at the Waco VA.

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