Drug-Device Combination Apps: The FDA's 3 Questions for Sponsors

On Oct. 20, 2026, the FDA released final guidance that sets out how the agency will apply its drug labeling authorities to apps and other software that drug sponsors distribute for use with their prescription medicines.¹ The document, Regulatory Considerations for Prescription Drug Use-Related Software, explains when app content is subject to FDA submission requirements, when an app should be described in a drug's prescribing information, and what sponsors should submit to the agency.²

Under the guidance, prescription drug use-related software generally means software that is disseminated by or on behalf of a drug sponsor and produces an output that supplements, explains, or is otherwise textually related to the sponsor's drug products.² This applies whether or not the software is regulated as a device. The FDA considers that output, meaning any content presented to a patient, caregiver, or health care practitioner, to be a type of prescription drug labeling. The scope covers prescription drugs and drug-led, drug-device combination products where the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research is the lead center.

“Mobile apps are playing a growing role in how patients manage their medications and health conditions,” said Captain Chris Wheeler, director of the Division of Medical Policy Programs, CDER, in a press release.¹ “This guidance helps ensure that the information these tools provide is accurate, evidence-based, and clearly communicated to both patients and their providers.”

How Does the FDA Distinguish Between Device-Connected and Standalone Apps?

The guidance identifies two categories of companion software.^1,2 Apps connected to a medical device, such as an app paired with an asthma inhaler, generally should be described in the drug's prescribing information because of the central role the software plays in how the medicine is used. Standalone apps, such as symptom trackers, dose reminders, or health coaching tools, belong in the prescribing information only if the sponsor can show the app is essential for safe and effective use or can demonstrate a meaningful clinical benefit. In most cases, the FDA will treat content displayed by a companion app as promotional material, consistent with how it handles other drug advertising.

Compared with the draft, the final version clarifies considerations for standalone software, adds a decision tree to guide labeling determinations, and provides sample prescribing information language for both categories.² It also recommends adding a statement to the prescribing information for device-connected software functions that show no meaningful improvement in a clinical outcome.

“This guidance reflects FDA's commitment to responsible, risk-proportionate oversight of digital health, an area that is a key priority for the agency and is evolving rapidly and holds significant promise for improving patient care,” said Michael Davis, director, CDER, in the press release.¹ “By aligning our approach across drug and device centers, we are giving developers a clear and consistent pathway to bring safe, effective digital health technologies to patients.”

Why Does this Matter for Development and Manufacturing Teams?

For sponsors developing connected inhalers, autoinjectors, and other combination products, the guidance moves software labeling decisions earlier in development.² Getting a standalone app into the prescribing information depends on clinical evidence, so that evidence needs to be planned into development programs rather than added after approval. Because the FDA treats app output as labeling, software updates may also need to run through the same change control and submission processes that govern other labeling. That will require closer coordination among regulatory, quality, and digital teams.

“Companion apps are quickly moving beyond simple dose reminders toward tools that adapt to each patient,” said Jared Seehafer, FDA, deputy commissioner for technology, in the press release.¹ “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.”

References

1. US Food and Drug Administration. FDA issues final guidance on prescription drug apps and software. Published October 20, 2026. Accessed October 20, 2026. View source

2. US Food and Drug Administration. Regulatory considerations for prescription drug use-related software; guidance for industry; availability. Federal Register. Public inspection document 2026-21516. Filed October 20, 2026. Scheduled for publication October 21, 2026. Accessed October 20, 2026. View source