Why is a SR or NSR Designation important? The FDA guidance document, “Information Sheet Guidance For IRBs, Clinical Investigators, and Sponsors: Significant Risk and Nonsignificant Risk Medical Device Studies,” sheds some light on the Investigational Device Exemptions (IDE) regulations of 21 CFR 812. The IDE regulations describe significant risk (SR), nonsignificant risk (NSR), and exempt...Read More

FDA released their CDRH Proposed Guidance Updates that includes a significant amount of “software related” guidance in FY 2021. There are four separate guidance documents listed for publication in FY 2021. IMO that is a fairly large commitment from the agency and I will look forward to reading about the agency’s “current thinking” on these...Read More