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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 allow digital health software products to reach market sooner based on FDA's validation of its design and testing processes

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