Human Research Protections
Definition: 

A device that presents a potential for serious risk to the health, safety, or welfare of a subject and:

  1. Is intended as an implant, or
  2. Is used in supporting or sustaining human life, or
  3. Is of substantial importance in diagnosing, curing, mitigating or treating a disease, or otherwise prevents impairment of human health, or
  4. Otherwise presents a potential for serious risk to the health, safety, or welfare of a subject.