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ARTICLE · 30 MAY 2018

FDA Releases Software Precertification Working Model

Jones Day
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As has been true generally across FDA's digital health endeavors, the working model notes that FDA is actively seeking public engagement on this topic.

United StatesFood, Drugs, Healthcare, Life Sciences
Jones Day
Jones Day
Alexis Gilroy
Alexis Gilroy
Ian Pearson
Ian Pearson
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On April 26, 2018, the U.S. Food and Drug Administration ("FDA") released an initial working model for its Software Precertification ("Pre-Cert") Pilot Program. The Pre-Cert Program is an effort by FDA to develop a new, more streamlined regulatory framework for software as a medical device ("SaMD") developed by manufacturers who have demonstrated a robust culture of quality and organizational excellence, and who are committed to monitoring real-world performance of their products once they are introduced into the U.S. market. Under the program, manufacturers that demonstrate these qualities may qualify for either an exemption from premarket review for lower risk SaMD products, or a faster review of higher risk products.

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