One Small Step For US FDA, But Maybe A Giant Leap For SaMDs

Regulators are one step closer to making the US Food and Drug Administration’s precertification program a reality. In a midyear update, the agency says an initial assessment has found its appraisal of manufacturer practices, rather than the products themselves, could be successfully used to make regulatory decisions on what software products get to market.

Unlike traditional medical devices, the FDA is concerned that its review processes currently on the books will not be able to keep up with the rapid pace of medical software...