What is the difference between a significant risk (SR) device and a non-significant risk (NSR) device?
A SR device is defined as an investigational device intended as an implant; for use in supporting or sustaining life; used in diagnosing, curing, mitigating, or treating disease; or otherwise presents a potential for serious risk to the health, safety, or welfare of a subject. A NSR device is generally any device that does not fit into the above criteria. Note: RK&S is available to assist you with the determination of SR or NSR status for the device of interest.
Related Questions
- How do I determine if the study is a significant or non-significant risk study and how do I determine if an invasive sampling technique presents a significant risk under 21 CFR 812.2(c)(3)?
- What are my responsibilities as the sponsor or the investigator of a study of a significant risk device subject to 21 CFR Part 812?
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