Digital Health Update: Mid-Year Update on Software Precertification Program

The Software Precertification (Pre-Cert) Program is reimagining how the FDA regulates digital health devices, specifically software as a medical device (SaMD). Since the FDA released the test plan in January 2019, we have been analyzing test cases and working with pilot participants to confirm the framework proposed in the Working Model v1.0 provides an equivalent reasonable assurance of safety and effectiveness for software products as compared to the traditional review pathway. While testing is underway, the FDA is committed to a collaborative and transparent Pre-Cert development process. The Mid-Year Update provides a summary of the Test Plan activities the FDA conducted through May 2019, as well as what we have learned. Questions? Email fdapre-certpilot@fda.hhs.gov

Read the Update (PDF)