Regulatory Considerations for Prescription Drug Use-Related Software; Guidance for Industry; Availability

FDA issued a final guidance titled "Regulatory Considerations for Prescription Drug Use-Related Software" on October 21, 2026, finalizing a draft guidance of the same title issued September 19, 2023 (88 FR 64443). The guidance describes how FDA intends to apply its drug labeling authorities under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to certain software outputs disseminated by or on behalf of a drug sponsor for use with a prescription drug product or a prescription drug-led, drug-device combination product assigned to the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER) as the lead center. The guidance defines "prescription drug use-related software" as software that is disseminated by or on behalf of a drug sponsor and produces an end-user output that supplements, explains, or is otherwise textually related to one or more of the sponsor's drug products, regardless of whether the software is regulated as a device under the FD&C Act. FDA classifies end-user output, meaning any material the software presents to a patient, caregiver, or healthcare practitioner, as a type of prescription drug labeling subject to FDA's labeling authorities. The final guidance addresses three specific areas: how FDA intends to apply its drug labeling authorities to end-user output; how the Prescribing Information (PI) should describe prescription drug use-related software functions; and when and how sponsors must submit end-user output to FDA for review. Changes from the draft to the final guidance include clarifying considerations for standalone software functions, introducing a decision tree for labeling determinations, providing illustrative PI language for device-connected and standalone software, and recommending addition of a PI statement for device-connected software functions for which there is no meaningful improvement in a clinical outcome. The guidance references existing FDA collections of information under OMB-approved control numbers, including 21 CFR part 314 (NDA/ANDA submissions, OMB 0910-0001), 21 CFR 601.2 and 601.12 (biologics license applications, OMB 0910-0338), 21 CFR 201.56 (prescription drug product labeling requirements, OMB 0910-0572), and Form FDA 2253 (OMB 0910-0001). The guidance is non-binding and does not establish rights for any person, consistent with FDA's good guidance practices regulation at 21 CFR 10.115.