FDA’s Digital Health Software Precertification (Precert) Program

Digital health technologies are moving forward toward rapid adoption in the United States. Yet, software developers are often apprehensive about the often long and detailed process of FDA’s premarket review. FDA’s new Digital Health Software Precertification (Precert) Program (“Precert Program”), announced in August 2017 (see our previous post here), seeks to pilot a “fast-track” process for developers of software-as-a-medical device that the FDA trusts to produce consistently high quality, safe and secure products, removing the necessity to undergo the full-blown design and validation review for each new software product.

In an article published in Digital Health Legal, titled “FDA’s Digital Health Software Precertification (Precert) Program,” Hyman, Phelps & McNamara, P.C.’s Jeffrey K. Shapiro, provides background to and discussion of FDA’s review processes and its new Precert Program, and considers the impact the Precert Program may have on the digital health market.