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 https://www.fda.gov/downloads/MedicalDevices/DigitalHealth/DigitalHealthPreCertProgram/ucm605685.pdf. Some trade press commentary is at http://www.mobihealthnews.com/content/fdas-pre-cert-plan-takes-shape-worries-emerge-about-overreach.
This is part of FDA’s Digital Health Software Precertification (Pre-Cert) Program (https://www.fda.gov/MedicalDevices/DigitalHealth/DigitalHealthPreCertProgram/default.htm).
Source: GARY CAPISTRANT, PATH Policy Advisor, Capistrant Consulting