September 29, 2022

FDA Releases New Digital Health Policy Resources

The Food and Drug Administration (FDA) published several digital health policy resources this week, including new final guidance documents related to implementation of the 21st Century Cures Act (“Cures Act,” 2016), a corresponding informational tool to determine whether a software function is FDA-regulated, and a report of takeaway lessons following completion of the 2017 Software Precertification Pilot Program.


  • The Software Precertification (Pre-Cert) Pilot Program: Tailored Total Product Lifecycle Approaches and Key Findings — The FDA published a report of lessons learned following completion of the 2017 Software Pre-Cert Pilot Program, which involved a “TSA Pre-Check” style approach for FDA to certify device manufacturers who could then leverage expedited regulatory pathways to the market for certain software devices. The FDA indicated that a Pre-Cert Program could be a viable approach in the future, but that new legislation would be necessary to supplement the agency’s authorities.

Guidance Documents

Other Resources

  • FDA Digital Health Policy Navigator — This informational tool helps stakeholders with their understanding of whether a particular software function is the focus of FDA regulatory oversight.

For any questions, please contact Michael Peters, American College of Radiology® Senior Government Affairs Director, Regulatory Policy.