Medical Devices

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.

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 Pre-Cert working model from the public through the public docket by March 8, 2019.

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.

DateEvent
January 7, 2019Publish Precertification Pilot Program Working Model version 1.0, 2019 Test Plan, and Regulatory Framework for Conducting the Pilot Program within Current Authorities
June 19, 2018Publish Precertification Program Working Model Update
May 10, 2018Digital Health Software Precertification User Session
April 26, 2018Publish Precertification Program Roadmap, Working Model and Challenge Questions
January 30-31, 2018Public Workshop: Developing the Software Precertification Program
November 17, 2017Digital Health Precertification Program Project Updates Webinar
Early October 2017Culture of Quality and Organizational Excellence (CQOE) Collection Plan and Appraisal Questions [XLS]
Early October 2017Series of Kick Off Meetings with Pilot Participants
Early October 2017Development of the Initial Software Precertification Program Model (PDF – 833 KB)
September 26, 2017Selection of Nine Pilot Program Participants
August 1, 2017Announcement of the Digital Health Action Plan and the Software Precertification Program
July 27, 2017Commissioner's Blog FDA announces new steps to empower consumers and advance Digital Healthcare

 

Page Last Updated: 01/07/2019
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