Glossary of Terms

21 CFR 812

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Clinical: MedTech
Guidelines & Standards

This part of the Code of Federal Regulations (CFR) contains the procedures and requirements governing the conduct of clinical research of devices. This research primarily addresses the safety and effectiveness of Investigation Device Exemptions (IDE). Device studies are categorized into three types according to the regulations of 21 CFR 812:  

  • Exempt studies: these studies are exempt from the requirements of 21 CFR Part 812. Examples of exempt studies include diagnostic device studies (e.g., in vitro diagnostic studies), consumer preference testing, and testing of a device modification.
  • Significant risk (SR) device studies: these studies require an approved IDE (Investigational Device Exemption) from the FDA and must comply with the regulations at 21 CFR 812.
  • Nonsignificant risk (NSR) device studies: these studies must meet the abbreviated IDE requirements at 21 CFR 812.2(b).