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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