FDA releases final guidance on prescription drug companion apps

The Food and Drug Administration released final guidance establishing a framework for how drug companies can develop, distribute, and label apps used alongside their prescription medicines. The guidance addresses when app content is subject to FDA submission requirements and when an app should be mentioned on a drug's official label.

The guidance identifies two categories of companion software. Apps connected to a medical device, such as an app paired with an asthma inhaler, generally should be described on the drug's official prescribing label. Standalone apps, such as symptom trackers, dose reminders, or health coaching tools, should appear on the prescribing label if the company can show the app is essential for safe and effective use or can demonstrate a meaningful clinical benefit.

Captain Chris Wheeler, Director of the Division of Medical Policy Programs within FDA's Center for Drug Evaluation and Research said mobile apps are playing a growing role in how patients manage their medications and health conditions. The guidance helps ensure that the information these tools provide is accurate, evidence-based, and clearly communicated to both patients and their providers.

Michael Davis, 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. By aligning the approach across drug and device centers, developers are given a clear and consistent pathway to bring safe, effective digital health technologies to patients.

Jared Seehafer, FDA Deputy Commissioner for Technology said companion apps are quickly moving beyond simple dose reminders toward tools that adapt to each patient. Finalizing this guidance gives drug companies and their technology partners a stable foundation to build on as these technologies advance and helps ensure patients and providers can trust the information they receive.

The agency aims to reduce unnecessary uncertainty for developers and manufacturers while preserving the safety and effectiveness standards that patients and healthcare providers rely on. Media inquiries may be directed to FDA Request for Comment 202-690-6343.