Food and Drug Administration

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

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