U.S. FDA· FDA·· 5 hours agoPickScore69
FDA Issues Final Guidance on Prescription Drug Apps and Software
In brief
FDA issued final guidance on October 20, 2026, establishing a framework for developing, distributing, and labeling apps and software that accompany prescription drugs. The guidance distinguishes two categories: companion apps connected to a medical device, such as an app paired with an inhaler, generally must be described in the drug's prescribing label, while standalone apps, such as symptom trackers, dose reminders, and health coaching tools, belong on the label only if shown to be essential for safe and effective use or to provide a significant clinical benefit.
Why it matters
The guidance clarifies labeling and submission requirements for prescription drug companion software and gives digital health tools a clear regulatory path.
Source: U.S. FDA