Medical Devices

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

Pilot Program Next Steps

The roadmap shows a high-level list of next steps that the FDA is exploring throughout the year to launch Pre-Cert 1.0. Once the FDA launches Pre-Cert 1.0, the agency will test and refine the program throughout the next year.

The FDA is building this roadmap based on user stories the agency has identified that describe Pilot Program features from a user's perspective. User stories describe the type of user, what they may want, and why they may want a specific Pilot Program feature.

The FDA is currently focused on three user types: FDA staff, health care system stakeholders (health care providers, patients, and payers), and software as a medical device manufacturers.

The FDA is building and iterating this list of next steps based on input the agency receives from the public.

Download the Pilot Program Roadmap

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.

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: 09/27/2018
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