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Precertification (Pre-Cert) Pilot Program: Milestones and Next Steps

Precertification (Pre-Cert) Pilot Program: Milestones and Next Steps

Pilot Program 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.

Submit Formal Comments on the Roadmap

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.

Date Event
May 22, 2019 Announce the opportunity for volunteers to participate in the Test the Plan for the Software Precertification (Pre-Cert) Program
January 7, 2019 Publish Precertification Pilot Program Working Model version 1.0, 2019 Test Plan, and Regulatory Framework for Conducting the Pilot Program within Current Authorities
June 19, 2018 Publish Precertification Program Working Model Update
May 10, 2018 Digital Health Software Precertification User Session
April 26, 2018 Publish Precertification Program Roadmap, Working Model and Challenge Questions
January 30-31, 2018 Public Workshop: Developing the Software Precertification Program
November 17, 2017 Digital Health Precertification Program Project Updates Webinar
Early October 2017 Culture of Quality and Organizational Excellence (CQOE) Collection Plan and Appraisal Questions [XLS]
Early October 2017 Series of Kick Off Meetings with Pilot Participants
September 26, 2017 Selection of Nine Pilot Program Participants
August 1, 2017 Announcement of the Digital Health Action Plan and the Software Precertification Program
July 27, 2017 Commissioner's Blog FDA announces new steps to empower consumers and advance Digital Healthcare