FDA Commissioner Outlines Next Steps for Pre-Cert Digital Health Pilot Program

    Jan. 9, 2019

    The U.S. Food and Drug Administration (FDA) has drafted a regulatory framework to test new approaches for the review of digital health device applications.

    In 2017, the FDA released its Digital Health Innovation Action Plan, while also unveiling a new precertification pilot program that would soften the regulatory requirements for digital health companies with a track record of developing and testing quality products.

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