• Is device a Significant Risk (SR) device or a Non-significant Risk device (NSR)?
• SR defined as:
  • "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 in 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 form serious risk to the health, safety, or welfare of a subject"
  • "otherwise presents a potential for serious risk to the health, safety, or welfare of a subject."

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