FDA Finalizes Guidance on Prescription Drug Apps. Some Apps Now Belong in the Prescribing Information.
Final guidance released Oct. 20 and noticed in the Federal Register Oct. 21 says device-connected apps should generally be described in a drug's prescribing information, while most companion-app content will be treated as promotional labeling.
On Oct. 20, the Food and Drug Administration finalized guidance saying apps paired with a drug's delivery device should generally be described in its prescribing information, and most companion-app content counts as promotional labeling.
The guidance, Regulatory Considerations for Prescription Drug Use-Related Software, was announced in the Federal Register on Oct. 21 under docket FDA-2023-D-2482. It finalizes a draft issued Sept. 19, 2023, and covers software outputs disseminated by or on behalf of a drug sponsor, according to the notice and the FDA's news release.
It is written for drug sponsors, not prescribers. Its effect on a clinic is indirect: it shapes which companion apps patients are handed, how their content is reviewed and whether the prescribing information you read mentions them.
What does the guidance cover?
It answers three questions, the FDA said: when app content is FDA-required labeling versus promotional labeling, when an app should be referenced in the prescribing information, and what companies should submit when they distribute app content. Like all guidance, it is not binding.
Apps connected to a device, such as one paired with an asthma inhaler, generally should be described in the prescribing information because the software is central to how the medicine is used. Standalone apps, such as symptom trackers, dose reminders and health coaching tools, belong there only if the sponsor shows they are essential for safe and effective use or deliver a meaningful clinical benefit. In most cases, content a companion app displays will be treated as promotional material, the FDA said.
What changed from the 2023 draft?
The Federal Register notice lists four changes: clearer considerations for standalone software, a decision tree for labeling determinations, sample prescribing-information language for device-connected and standalone software, and a recommended prescribing-information statement for device-connected functions that show no meaningful improvement in a clinical outcome.
The Regulatory Affairs Professionals Society, in its summary, added that sponsors need not resubmit app output for software updates that do not change previously submitted content, and that the FDA may issue more guidance on certain updates as it gains experience.
An app that reaches your patient through the manufacturer is regulated as part of the drug's labeling. An app the patient finds on their own is outside this guidance.
What did FDA officials say?
“Mobile apps are playing a growing role in how patients manage their medications and health conditions,” said Capt. Chris Wheeler, PharmD, director of the Division of Medical Policy Programs in the FDA's Center for Drug Evaluation and Research, in the release. Michael Davis, MD, PhD, the center's director, said the guidance reflects “responsible, risk-proportionate oversight of digital health.” Jared Seehafer, the FDA's deputy commissioner for technology, said “companion apps are quickly moving beyond simple dose reminders toward tools that adapt to each patient.”
What to watch
Expect more prescribing information that names an app, which gives you a labeled basis to recommend it, and more manufacturer apps that carry promotional content. Treat a manufacturer app as you would a sponsor-funded patient handout: useful, but check what evidence supports it, and read any prescribing-information statement saying a connected function has not been shown to improve outcomes.
If your practice evaluates digital tools more broadly, our guide to choosing AI tools covers the questions to ask before deployment.
Reported, fact-checked and edited by The Script Pad's editorial staff.
This article is for professional education and does not replace clinical judgment. Treatment decisions should be based on the individual patient and current guidelines.
