Tag Archives: Digital

HIV self-test app connects users to care, FDA proposes De Novo update, and more digital health news briefs

De Novo rule proposal published for review. The FDA has published a new proposal for revisions to the De Novo regulatory pathway for devices without a predicate. The rule, which is currently available for public comment, aims to provide additional structure, clarity and transparency to the process, and outlines how the agency processes and gauges… Read More »