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Glossary

Significant risk device

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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 a 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 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. 

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