Digital Health: Significant FDA Policy Developments In 2022 - Healthcare
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...
Scott Gottlieb Software Precertification Program Precertification Program International Medical Device Regulators Forum Precert Program Health It Report Proposed Strategy
Source: mondaq.com