Pre-Cert Pilot Program Next Steps
The FDA is testing the
Pre-Cert model (PDF) 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 that is 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 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.
Event 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
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
Content current as of: