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 that are not well suited for faster and more iterative design, development, and validation techniques applied to develop high quality, safe, and effective software, including software as a medical devices (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.