The U.S. Food and Drug Administration (FDA) released final guidance on October 20, 2026, establishing a framework for how drug companies must develop, distribute, and label apps used alongside prescription medicines. The guidance aims to clarify when app content requires FDA submission and how software should be described on medication labels.
The guidance addresses three primary questions for industry: when app content is considered FDA-required labeling versus promotional material, when an app should be referenced in a drug’s official prescribing information, and what companies must submit to the agency.
The FDA identifies two categories of companion software:
- Apps connected to a medical device: These, such as an app paired with an asthma inhaler, generally require description on the drug’s official prescribing label due to their central role in how the medicine is used.
- Standalone apps: These, including symptom trackers, dose reminders, or health coaching tools, should appear on the prescribing label if the company can demonstrate the app is essential for safe and effective use or provides a meaningful clinical benefit.
Regarding content, the guidance states that information a companion app displays to users will be treated as promotional material, consistent with how the FDA handles other drug advertising. The agency emphasized that this framework reflects a commitment to modernizing regulations to keep pace with digital health technologies while maintaining safety and effectiveness standards.
