Precertification (Pre-Cert) Pilot Program: Milestones and Next Steps
The FDA is testing the Pre-Cert model with a limited number of organizations. During the 2019 testing, the FDA will apply both the Pre-Cert model and the traditional review process to each premarket submission. In this way, the FDA hopes 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.
If you are a company of Software as a Medical Device planning to submit a premarket application in 2019 and have already submitted a Q-Sub or are about to submit a Q-Sub, you may be eligible to volunteer to be a Test Plan participant.
The FDA will use the results from testing the model in 2019 to develop a framework for a future Pre-Cert model, in which digital health software developers that have successfully been excellence appraised could directly introduce lower-risk products to the market.
The FDA continues to seek input on the program from the public through the public docket.
This section lists completed actions and events in the Pre-Cert Pilot Program from now to the program inception in July 2017.