Software as a Medical Device: FDA Update in May 2018

Until May 31, the U.S. Food and Drug Administration (FDA) has open for comment from the public a proposal for precertification of software as a medical device. Its 17-page proposal is located at Some trade press commentary is at This is part of FDA’s Digital Health Software Precertification (Pre-Cert) Program ( Source: GARY CAPISTRANT, PATH Policy Advisor, Capistrant Consulting