Digital Health Software Precertification (Pre-Cert) Pilot Program

Read the Pre-Cert Report

Software Pre-Cert Pilot Program

In September 2022, the Software Precertification (Pre-Cert) Pilot Program was completed with the issuance of the Report: The Software Precertification (Pre-Cert) Pilot Program: Tailored Total Product Lifecycle Approaches and Key Findings.

The FDA launched the Software Precertification (Pre-Cert) Pilot Program ("the pilot") in 2017 to foster innovative technologies and advance FDA's mission to protect and promote public health. The pilot explored innovative approaches to regulatory oversight of medical device software developed by organizations that have demonstrated a robust culture of quality and organizational excellence and who are committed to monitoring real-world performance of their products once they reach the U.S. market. With this report, the FDA is marking the completion of the pilot.

This pilot was an important first step to help explore and evaluate the program model to inform development of an adaptive regulatory approach. Based on the observations from the pilot discussed in this report, FDA has found that rapidly evolving technologies in the modern medical device landscape could benefit from a new regulatory paradigm, which would require a legislative change.

Resources

This section lists completed actions and events in the Pre-Cert Pilot Program from the program inception in July 2017 to completion of the pilot in September 2022.

Date	Event
September 26, 2022	The Software Precertification (Pre-Cert) Pilot Program: Tailored Total Product Lifecycle Approaches and Key Findings
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
April 26, 2018	Published Precertification Program Roadmap, Working Model, and Challenge Questions
January 30-31, 2018	Public Workshop: Developing the Software Precertification Program
Early October 2017	Culture of Quality and Organizational Excellence (CQOE) Collection Plan and Appraisal Questions [XLS]
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

Questions?

Please email the Digital Health Center of Excellence at DigitalHealth@fda.hhs.gov with any questions.