Digital Health Legal
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Volume: 4 Issue: 11
(November 2017)

fdas digital health software precertification (precert program despite world leader development digital health technologies developers us often apprehensive often

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The FDA’s Digital Health Software Precertification (Precert) Program

Despite being a world leader in the development of digital health technologies, developers in the US are often apprehensive about the often long and detailed process of the Food and Drug Administration’s (‘FDA’) premarket certification review. The FDA’s new Digital Health Software Precertification (Precert) Program (‘Precert Program’), announced in August 2017, seeks to pilot a ‘fast-track’ process for software as a medical device (‘SAMD’) developers that the FDA trusts to produce consistently high quality, safe and secure products, removing the necessity to undergo the full review process for each product produced. Jeffrey K. Shapiro, Director at Hyman, Phelps & McNamara, provides background to and discussion of the FDA’s review processes and its new Precert Program, and considers the impact the Precert Program may have on the digital health market.

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