FDA Finalizes Guidance on Prescription Drug Use-Related Software
FDA's final PDURS guidance adds a labeling decision tree, a formal "standalone" software category, and model prescribing-information language for companion apps, sharpening when app output is FDA-required versus promotional labeling.
On October 20, 2026, FDA announced final guidance titled Regulatory Considerations for Prescription Drug Use-Related Software, completing a process begun with a September 2023 draft and a 2018 Federal Register request for comments. The guidance addresses software disseminated by or on behalf of a drug sponsor that generates "end-user output" textually related to the sponsor's drug products, and treats that output as a form of drug labeling even where the software itself is not a regulated device.
Four changes from the draft are identified in the Federal Register notice: a formal "standalone" function category (functions not relying on device data) that generally should not be described in prescribing information unless the function is necessary for safe and effective use or the sponsor can show meaningful clinical-outcome improvement; a four-question labeling decision tree (Appendix A); illustrative PI language for device-connected and standalone software (Appendices B and C), including a model statement that the associated mobile app "is not necessary for safe and effective use" of the drug; and Form FDA 2253 implications where output is promotional labeling.
Sponsors with companion apps should decide early whether to seek PI inclusion and what evidence supports it, engage the relevant FDA review division before development, and audit third-party dissemination channels, since developer distribution on a sponsor's behalf can pull the software inside the guidance.