FDA issues final guidance on prescription drug apps and software
The FDA released final guidance on October 20, 2026 that clarifies when app content is subject to FDA submission requirements and when it should be mentioned on a drug's official label. The guidance identifies two categories of companion software-apps connected to a medical device and standalone apps-and sets conditions for labeling and what companies should submit to the agency.
Primary source
FDA press announcement, October 20, 2026
FDA Issues Final Guidance on Prescription Drug Apps and Software
Read the source: FDA Issues Final Guidance on Prescription Drug Apps and Software fda.gov
Machine-summarized from the source above; not independently reported. How we use automation