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Industry Praise US FDA Software Pilot Program

Medtech sector representatives say they are optimistic about FDA's plans to accept up to nine companies to participate in a pilot program that could lead to a new pathway for digital health products.

Industry advocates who have been encouraging US FDA to open a new regulatory pathway for digital health software are commending the agency for announcing a pilot program to explore the viability of allowing products to get to market sooner when developed by a software developer who has established FDA's trust.

FDA recently announced a pilot for its Digital Health Software Precertification Program, or PreCert, which is part of the agency's broader Digital Health Innovation Action Plan. PreCert is intended to...

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