FDA Pilot SaMD Precertification Program Offers Few Insights
Along with many of our clients, we at Enzyme looked to the FDA pilot program for software precertification as a potential solution to many of the problems with the agency’s regulation of software as a medical device (SaMD). Unfortunately, it appears the precertification pilot was less than successful in providing a new regulatory path forward, the consequence of which is that many SaMD products will continue to require burdensome and frequent regulatory filings.