Risk Classification




Risk Classification

Exempt
A device is considered exempt as long as the sponsor complies with the requirements at 21 CFR 809.10(c) for labeling, and if the testing:

  • Is noninvasive;
  • Does not require an invasive sampling procedure that presents significant risk;
  • Does not by design or intention introduce energy into a subject; and
  • Is not used as a diagnostic procedure without confirmation of the diagnosis by another, medically established diagnostic product or procedure. 21 CFR 812.2(c)(3).

Non Significant Risk
A non significant risk device is one that does not meet the definition for an exempt or significant risk device.

Significant Risk
Under 21 CFR 812.3(m), a significant risk device means an investigational device that:

  • Is intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject;
  • Is purported or represented to be for use supporting or sustaining human life and presents a potential for serious risk to the health, safety, or welfare of a subject;
  • Is for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject; or
  • Otherwise presents a potential for serious risk to the health, safety, or welfare of a subject.