Federal Register #2026-21516

FDA Final Guidance on Prescription Drug Use-Related Software

The FDA announces final guidance for software used with prescription drugs and certain drug-device combination products. - Government agency: U.S. Department of Health and Human Services, Food and Drug Administration (FDA); no sub-agency or specific office is identified. - Notice type: Guidance-availability announcement, not a procurement opportunity or contract award. - Guidance focus: Explains how FDA applies drug-labeling authorities to software outputs disseminated by or for a drug sponsor, including outputs intended for use with prescription drugs or certain drug-device combination products. - Key topics: How required labeling should describe software functions; when and how sponsors should submit software outputs for FDA review; considerations for standalone software functions; and statements for certain device-connected software functions. - Resources included: A decision tree and illustrative language for prescribing information. - OEMs and vendors: None identified. - Products, services, quantities, and part numbers: None requested or specified.

Description

The Food and Drug Administration (FDA) announces the availability of its final guidance for industry, “Regulatory Considerations for Prescription Drug Use-Related Software.” The guidance describes FDA’s application of drug labeling authorities to certain software outputs disseminated by or on behalf of a drug sponsor for use with a prescription drug or a prescription drug-led, drug-device combination product assigned to CDER or CBER as the lead center. It explains how FDA intends to apply labeling authorities to software outputs, how FDA-required labeling should describe the software functions, and when and how sponsors should submit outputs for FDA review. The final guidance updates and replaces the draft guidance issued September 19, 2023.

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