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;
- For use in supporting or sustaining human life and represents a potential for serious risk to the health, safety, or welfare of a subject;
- 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 a subject.
