In September 2022, the FDA Software Precertification Pilot Ends, or has officially “completed” the Software Precertification (Pre-Cert) Pilot Program. See: https://www.fda.gov/medical-devices/digital-health-center-excellence/digital-health-software-precertification-pre-cert-pilot-program?utm_medium=email&utm_source=govdelivery
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. SoftwareCPR Post from 2019
The major findings in this report:
- The Pilot Program is complete, and for now there is no Software Pre-Certification Program
- FDA has determined that the approach described in the pre-certification working model is not practical to implement under our current statutory and regulatory authorities.
- The pilot informed what new statutory authorities could support a future regulatory paradigm that builds on these concepts.
- Appropriate new legislative authority would be necessary to support the development and implementation of a new regulatory paradigm.
In the meantime, FDA, with leadership from CDRH’s Digital Health Center of Excellence, will continue to develop policies and tools within current authorities to improve the efficiency and effectiveness of regulatory oversight, including through collaborative engagement with the public, such as the Medical Device Innovation Consortium (MDIC).
Download the report: The Software Precertification (Pre-Cert) Pilot Program: Tailored Total Product Lifecycle Approaches and Key Findings