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125. FDA Regulations: Investigational Devices (21 CFR 800)

Research to assess the safety or effectiveness of a device must have an IDE (§812) issued by the FDA, unless the research is exempt from the requirement for an IDE or meets the requirements for an abbreviated IDE. These regulations also apply to clinical studies of a new indication for an FDA-approved device.

The University requires an investigator form for device research.

The University Biomedical IRB reviews all human subject research conducted under an IDE at convened meetings, unless an approved protocol meets the criteria for expedited continuing review under Categories 8(a), 8(b), or 8(c); or expedited review of minor modifications.

In presenting the protocol to the IRB, the primary reviewer will address the additional FDA regulatory requirements. The IRB will confirm one of the following is true:

  • the device has an IDE issued by the FDA;
  • the device is exempt from the requirements for an IDE; or
  • the device meets the criteria for an abbreviated IDE (only for non-significant risk devices).

Information about IDEs may be obtained

  • from the commercial sponsor protocol,
  • via communication from the sponsor, or
  • via communication from the FDA.

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