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FDA unveils working model for software precertification program

April 27, 2018


The Food and Drug Administration has released a draft working model for a new software precertification program for developers, with the intent of fast-tracking digital health products to market.

“The goal of this program is to develop a tailored and pragmatic approach that trusts the excellence of organizations, but also continually verifies the safety, effectiveness and performance of software as a medical device,” said FDA Commissioner Scott Gottlieb, MD, who announced the availability of the document Thursday at the Health Datapalooza conference in Washington.

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