Pre-Cert Pilot Program Next Steps

The FDA has conducted testing under the Pre-Cert model (PDF) with a limited number of organizations. During the testing, the FDA applied both the Pre-Cert model and the traditional review process to each premarket submission. The goal of the testing was to show that the excellence appraisal and streamlined premarket review reap the same quality of information that the FDA can rely on when determining a software developer's products meet our safety and effectiveness standard, as compared to the FDA's traditional approach to review these devices.  FDA’s 2020 Update document describes the progress to date. Going forward, FDA will continue to iterate, build and test the model.

The Working Model describes the future vision for the program.

The FDA continues to seek input on the program from the public through the public docket.

Submit Formal Comments

Past Pilot Program Milestones

This section lists completed actions and events in the Pre-Cert Pilot Program from now to the program inception in July 2017.