Trimming Back the Burden of FDA’s Software Regulation
June 12, 2018 - Online ON CAWebinar Compliance
info@webinarcompliance.com
Phone:1-416-915-4438 / 58
FDA no longer regulates low risk software, premarket guidance documents must be revised or withdrawn, firms can give themselves 510(k) market clearance rather than FDA, firms can substitute requirement of Reports of Corrections and Removals by participating in a voluntary self-help initiative. Perhaps the most beneficial change for everyone is FDA’s participation with the National Institute of Standards and Technology (NIST) to recognize NIST’s reports, which can be used as guidance.
This website uses cookies to ensure you get the best experience on our website. Learn more