FDA releases update on digital health software precertification pilot programme

The US Food and Drug Administration (FDA) published an update on digital health software precertification (pre-cert) programme. The pre-cert programme was launched in 2019 to address the challenge that the FDA’s traditional approach to regulate hardware-based medical devices is not well suited for the faster and more iterative design, development, and validation techniques applied to develop high quality, safe, and effective software, including software as a medical device (SaMD). The update unpacks learnings to date from the building and testing of the pre-cert pilot programme. It also underscores  that the COVID-19 pandemic further highlights the importance of enabling rapid access to safe and effective devices for public health.