U.S. FDA· FDA·· 5 hours agoPickScore59
Regulatory Considerations for Prescription Drug Use-Related Software
In brief
FDA announced the final guidance "Regulatory Considerations for Prescription Drug Use-Related Software" (Docket FDA-2023-D-2482), establishing that drug labeling authorities apply to software outputs disseminated by or on behalf of a drug sponsor for use with prescription drugs or drug-led drug-device combination products. The draft version was issued on September 19, 2023.
Why it matters
FDA's final guidance clarifies how labeling authorities apply to prescription drug-related software outputs, supporting compliance for digital health tools.
Source: U.S. FDA