USA – FDA updates Pre-Cert pilot for SaMD

Lessons learned from a digital health software pilot pre-certification program have readied the US Food and Drug Administration (FDA) to test an updated version of the continuous evaluation program for developers of software as a medical device (SaMD).

The precertification (Pre-Cert) pilot “will help inform the development of a future regulatory model that will provide more streamlined and efficient regulatory oversight of software-based medical devices,” said FDA in a new Q&A webpage about the pilot program. The Pre-Cert program will be available for “manufacturers who 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 US market,” said the agency…