In 2022, FDA retreated from a flexible approach to its regulation of digital health in two key areas: (1) its PreCertification Program for software as a medical device (SaMD) and (2) its guidance.
2022 was a big year for the pharmaceutical and biotechnology sectors. Novel technologies emerged at a rapid clip. The Food and Drug Administration (“FDA” or the “Agency”) approved over.
Facing novel, swiftly evolving technologies in the digital health space, the US Food and Drug Administration has been trying to balance fostering innovation with providing reasonable.