Drug-labeling guidance finalized
FDA announced its final guidance on prescription drug use-related software on October 20, 2026; the Federal Register notice followed on October 21. It addresses software outputs distributed by or on behalf of drug sponsors for prescription medicines and drug-led combination products assigned to the Center for Drug Evaluation and Research (CDER) or Center for Biologics Evaluation and Research (CBER). FDA announcement; guidance scope
The document finalizes the September 2023 draft. Additions include a labeling decision tree, clearer treatment of standalone software, and examples of prescribing-information language. The document provides nonbinding recommendations under existing drug-labeling authorities. Federal Register notice
App output and prescribing information are separate questions
FDA generally treats covered software output as drug labeling. Whether that output is FDA-required labeling or promotional labeling depends on the software’s role and supporting evidence.
Output generally falls within FDA-required labeling when it is essential to safe and effective use, or when FDA finds evidence that the software delivers a meaningful improvement in a clinical outcome. The latter pathway calls for adequate and well-controlled studies.
Device-connected functions should typically be described in prescribing information even when optional and without demonstrated clinical improvement. Their output may nevertheless be promotional labeling. FDA recommends stating when the connected software is not necessary for safe and effective use of the medicine. Standalone functions generally should not appear in prescribing information unless essential to safe and effective use or supported by evidence of meaningful clinical improvement.
Existing submission requirements remain relevant, including Form FDA 2253 for promotional output. That form does not replace a required device marketing submission.
The guidance does not change the statutory or regulatory device framework or determine whether a software function is a medical device. Sponsors still need a separate device-regulatory assessment where relevant. Final guidance, sections I, IV and Appendix A
Sources
- Primary official sourceRegulatory Considerations for Prescription Drug Use-Related Software: Guidance for Industry (opens in a new tab)U.S. Food and Drug Administration
- Supporting sourceFDA Issues Final Guidance on Prescription Drug Apps and Software (opens in a new tab)U.S. Food and Drug Administration
- Supporting sourceRegulatory Considerations for Prescription Drug Use-Related Software (opens in a new tab)U.S. Food and Drug Administration
- Supporting sourceRegulatory Considerations for Prescription Drug Use-Related Software; Guidance for Industry; Availability (opens in a new tab)U.S. Food and Drug Administration, Federal Register