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...Read More