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.