October 11, 2017

Digital Health Software PreCert Program Participants Announced; Approach May Have Other Applications

Gottlieb Says Certifying Digital Health Tech Companies May Be an Element in ‘Modern’ Approach to LDTs


The FDA has announced the names of the nine digital health technology manufacturers that will participate in the agency’s pilot Digital Health Software Precertification (PreCert) Program.

Under the program’s approach, the FDA “will become a ce...

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