Program may expand by end of 2018 . . .

Companies Praise FDA's Collaborative Approach Toward Software Pre-Cert Pilot

February 02, 2018
The nine major medical device and technology companies selected by FDA last fall to be a part of the agency's digital health pre-cert pilot program praised the agency and the program at a two-day public workshop held this week at the National Institutes of Health. Companies said they were pleasantly surprised by FDA's willingness to work cooperatively with companies to develop a regulatory framework that encourages innovation in medical software development. FDA hopes to get a version of the pre-cert...

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