Submitted by kkg4003 on August 15, 2023 - 5:29pm
Definition:
A device that presents a potential for serious risk to the health, safety, or welfare of a subject and:
- Is intended as an implant, or
- Is used in supporting or sustaining human life, or
- Is of substantial importance in diagnosing, curing, mitigating or treating a disease, or otherwise prevents impairment of human health, or
- Otherwise presents a potential for serious risk to the health, safety, or welfare of a subject.