Attached is a pdf of the testimony of FDA’s Director of CDRH Jeff Shuren regarding Health Information Technology Policy. It discusses the need for active regulation FDA regulation, the possible approaches to regulation, and the regulatory basis for this. The Appendix provides some examples of adverse events associated with such systems. It identifies four categories:...Read More
CSV Training Course
Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email firstname.lastname@example.org for more info.