FDA issues final guidance on prescription drug companion app labeling
The FDA has released final guidance clarifying when software used alongside prescription drugs must be included in a drug's official label and submitted for agency review, establishing a clear regulatory pathway.
The U.S. Food and Drug Administration issued final guidance on October 20, 2026, specifying when companion app content should be included in a drug's official prescribing information and how sponsors must submit end-user output. The guidance resolves longstanding industry uncertainty by providing recommendations about when app content is subject to FDA submission requirements, when an app should be mentioned on a drug’s official label, and what companies should submit to the agency.
Jared Seehafer, M.S., FDA Deputy Commissioner for Technology, said companion apps are moving beyond simple dose reminders toward tools that adapt to each patient. The FDA defines prescription drug use-related software as software disseminated by or on behalf of a drug sponsor that produces an end-user output that supplements, explains, or is otherwise textually related to one or more of the sponsor’s drug products. This output is considered a type of prescription drug labeling.
The guidance categorizes companion software into two distinct types with different labeling requirements based on their role in medication use.
FDA categorizes companion software types
The guidance distinguishes between device-connected apps and standalone apps. Software connected to a medical device, such as an app that pairs with an asthma inhaler, should be included in the drug’s official prescribing label because of the significant role it plays in the usage of the medication.
Standalone apps, including symptom trackers, dose reminders, or health coaching tools, should also be mentioned on the prescribing label if the company can demonstrate that the app is essential for the safe and effective use of the product or if it can show a meaningful clinical benefit. In most cases, content a companion app displays to users will be treated as promotional material, consistent with how the FDA handles other drug advertising.
The final draft clarifies considerations for standalone software functions and introduces a decision tree to guide sponsors through labeling determinations. It provides examples of Prescribing Information language for both software types and recommends adding a PI statement for device-connected software functions that do not demonstrate meaningful improvement in a clinical outcome.
FDA emphasizes safety and regulatory clarity
The guidance aims to reduce uncertainty for developers and manufacturers while preserving safety and effectiveness standards. Michael Davis, M.D., Ph.D., Director of the FDA’s Center for Drug Evaluation and Research, said the guidance reflects FDA’s commitment to responsible, risk-proportionate oversight of digital health.
Captain Chris Wheeler, Pharm.D., Director of the Division of Medical Policy Programs within FDA’s Center for Drug Evaluation and Research, stated that mobile apps are playing a growing role in how patients manage medications and health conditions. "Mobile apps are playing a growing role in how patients manage their medications and health conditions," Wheeler said. The guidance helps ensure that the information these tools provide is accurate, evidence-based, and clearly communicated.
The agency said it plans to concentrate its review of end-user output on factors that could impact the safe and effective use of the drug, including considerations related to promotional labeling. Sponsors do not need to resubmit end-user output for software updates that do not alter the content of previously submitted outputs. The FDA finalized the guidance to address how sponsors can develop, distribute, and label software applications used alongside prescription medicines, revising a draft issued in September 2023.
