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.