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  5. Precertification (Pre-Cert) Pilot Program: Milestones and Next Steps
  1. Digital Health Software Precertification (Pre-Cert) Program

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

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.

Date Event
Sept. 14, 2020 2020 update on progress of the Pre-Cert Pilot Program
July 18, 2019 Mid-year update on progress of the Pre-Cert Pilot Program
May 22, 2019 Announced opportunity for volunteers to participate in the Test Plan for the Software Precertification (Pre-Cert) Program
January 7, 2019 Published 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 Published Precertification Program Working Model Update
May 10, 2018 Digital Health Software Precertification User Session
April 26, 2018 Published 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 Selected Nine Pilot Program Participants
August 1, 2017

Announced the Digital Health Action Plan and the Software Precertification Program

July 27, 2017 Announced new steps to empower consumers and advance digital healthcare

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