FDA releases working model for Software Precertification Pilot Program

Last week, FDA released updates to its Software Precertification (Pre-Cert) Pilot Program, including release of a working model reflecting the Agency's vision of the pilot and outlining its most critical components. The Pre-Cert Program is an effort by FDA to develop a regulatory framework for software medical device products through which a company is deemed to have good internal design, development, and production processes/practice and is given a streamlined (or exemption from) pre-market review for future software products.

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