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When is a project regulated by the FDA?

A project is FDA-regulated if data will be sent to the FDA OR if any of the following are part of the project:

  •  approved drug, device, biologic, or humanitarian use device (HUD)
  •  investigational new drug (IND) exempt (drug, biologic)
  • investigational device evaluation
  •  investigational device: exempt
  •  investigational device: significant risk (SR)
  •  i.e., intended as an implant or for supporting/sustaining human life or used in diagnosing, curing, mitigating, or treating diseases AND/OR presents a potential for serious risk to a participant
  • examples: dental lasers, embolization devices for urological use, collagen and bone replacements
  •  investigational device: nonsignificant risk (NSR)
  •  i.e., does not meet the definition of significant risk
  •  examples: external monitors for insulin reactions, general biliary catheters, MRI within specified parameters
  •  investigational drug, biologic.

The project would not be FDA regulated if:

  •  a drug or device is used but is not the focus of the study AND no data are being collected about the drug or device for submission to or inspection by the FDA
  • it is a retrospective or prospective medical records review AND the data is NOT submitted to the FDA.