Digital Health Update: The FDA Announces an Opportunity for Test Case Volunteers for the Test Plan for the Software Precertification Program

The U.S. Food and Drug Administration (FDA) is announcing an opportunity to be part of the FDA’s Test Plan for the Software Precertification (Pre-Cert) Program.  The opportunity is for companies who plan in the next year to submit a De Novo Request or 510(k) submission for software as a medical device (SaMD).

In 2019, the Software Pre-Cert program entered its test phase. In January, the FDA shared the Test Plan, which outlines how the FDA intends to iterate and confirm that the framework proposed in the Working Model provides a reasonable assurance of safety and effectiveness for software products. The FDA’s Test Plan is designed to assess whether the Excellence Appraisal and Streamlined Review components together produce an equivalent basis for determining reasonable assurance of safety and effectiveness for a software device prior to its introduction to the market, as compared to the FDA’s traditional models. The FDA Pre-Cert team would like to hear from companies who plan in the next year to submit a premarket application for a SaMD, and who would like to participate with test cases in the Software Pre-Cert Test Plan. Continue Reading