Tag Archives: Pre-Cert

What physicians are reading about digital health

There are two papers in the May 15 volume of the Annals of Internal Medicine that discuss digital health applications and are illustrative of the topics being considered by physicians as they evaluate the adoption and impact of digital solutions.  These papers serve as examples of the active dialogue taking place around the appropriate regulatory … Continue Reading

FDA Initiates Software Precertification Pilot Program

On Friday, July 28, FDA announced a new Software Pre-certification (Pre-Cert) Pilot Program in a Federal Register notice.  The Pre-Cert program is one of three main action items discussed in the agency’s recently-released Digital Health Innovation Action Plan.  CDRH also held a webinar on August 1 to provide an overview of the program and answer … Continue Reading
LexBlog