By: Akanksha
The U.S. Food and Drug Administration (FDA) released final guidance, Regulatory Considerations for Prescription Drug Use-Related Software, on Tuesday, October 20, 2016. The policy establishes a framework for how drug sponsors can develop, distribute, describe, and label apps that are used with their prescription medicine.
The FDA noted that the guidance aims to address long-standing uncertainty by identifying when content in an app is subjected to FDA submission requirements, when an app should be referenced in a drug’s official labelling, and what information should be submitted to the agency.
The FDA’s final guidance is a vital step in its effort to modernize regulations to keep up with the rapid advances of digital health technologies, reducing unwarranted uncertainty to developers and manufacturers while still protecting and promoting the safety and effectiveness of healthcare products and services for patients and providers.
Under the FDA’s final guidance, prescription drug use-related software generally refers to software that is distributed by or on behalf of a drug sponsor and produces an “end-user output” that supplements, explains, or is otherwise textually related to one or more of the sponsor’s drug products, regardless of whether the software is regulated as a medical device. The scope covers prescription drugs and drug-led, drug-device combination products for which the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research is the lead center.
End-user output generally refers to any content presented to an end user — patient, caregiver, or healthcare practitioner — by the software and is considered a form of prescription drug labelling, regardless of whether the drug sponsor or a technology partner builds the application. This scope also extends to adherence and coaching tools provided as part of manufacturer patient support programs when such tools are provided by the sponsor or its vendor.
The FDA’s final guidance addresses three important questions for the industry:
When is content in an app considered FDA-required labelling versus promotional labelling?
When should an app be included or referenced in a drug’s official prescribing information (PI)?
What should companies submit to the FDA — and when and how should they submit end-user output for review — when they distribute app content to users?
The guidance categorizes companion software into two distinct categories: device-connected apps and standalone apps. In most cases, the content a companion app displays to users will be treated as promotional material, in line with the FDA’s approach to other forms of drug advertising.
The first category covers software connected to a medical device, such as a companion app paired with an asthma inhaler. According to the FDA, this type of software should generally be described in the drug’s official prescribing label because of the central, significant role the software plays in how the medication is used.
The second category covers standalone apps, which include symptom trackers, dose reminders, or health coaching tools. According to the FDA, these apps should be included in the official prescribing label only if the company can show that the app is essential for the safe and effective use of the drug or can demonstrate a meaningful clinical benefit.
The final guidance revises the draft guidance issued on September 19, 2023, with a Federal Register notice specifying several updates and terminology changes.
Clarifying the considerations for standalone software functions.
Replacing the term “digital health technologies” with “software with prescription drug”
Introducing an updated Appendix A, which includes a decision tree to guide sponsors through labelling determinations related to prescription drug-use software
Providing an updated Appendix B with illustrative examples of PI language for both device-connected software and standalone software, describing the constituent parts of the device and the connected software functions within the prescribing information
Recommending the addition of a statement within the PI for device-connected software functions that do not demonstrate a “meaningful improvement in a clinical outcome”
The Federal Register notice also notes that the recommendations are intended to align with initiatives across the FDA’s product centers, including digital health work at the Center for Devices and Radiological Health, to support coordinated review when the software is also reviewed as a device.
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According to the FDA, sponsors do not need to resubmit end-user output for software updates that do not alter the content of previously submitted outputs. The agency plans to concentrate its review of end-user output on factors that could impact the safe and effective use of the drug, including considerations related to promotional labelling.
“As FDA gains more experience with the Post-Market Drug Utilization Review System (PDURS) including updates to end-user output from PDURS submitted to FDA, we may provide additional guidance for certain kinds of updates/changes to end-user output,” the FDA stated.
The final guidance provides a defined test for sponsors to evaluate companion app content, carrying practical implications for how companies plan and manage their digital tools.
For sponsors developing connected inhalers, autoinjectors, and other combination products, the guidance moves software labelling decisions to earlier stages of development. Because obtaining a standalone application for inclusion in the prescribing information requires clinical evidence, such support should be designed into development programs that are pursued beyond regulatory approval. Additionally, since the FDA treats app output as drug labelling, software updates may need to run through the same change control and submission processes that govern other drug labelling, requiring closer coordination among regulatory, quality, and digital teams.
FDA officials noted the growing role of companion apps and the need for clear regulatory oversight.
“Mobile apps are playing a growing role in how patients manage their medications and health conditions. This guidance helps ensure that the information these tools provide is accurate, evidence-based, and clearly communicated to both patients and their providers,” said Captain Chris Wheeler, Phar.D., Director of the division Medical Policy Programs within CDER in a press release.
Michael Davis, M.D., Ph.D., Director of CDER noted that 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. By aligning our approach across drug and device centers, they are giving developers a clear and consistent pathway to bringing the same effective digital health technologies to patients in the press release.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.
The agency also is responsible for the safety and security of the nation’s food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.
References:
1. U.S. Food and Drug Administration. “FDA Issues Final Guidance on Prescription Drug Apps and Software.” Press release, October 20, 2026. https://www.fda.gov/news-events/press-announcements/fda-issues-final-guidance-prescription-drug-apps-and-software.
2. 1. U.S. Department of Health and Human Services, Food and Drug Administration. “Regulatory Considerations for Prescription Drug Use-Related Software: Guidance for Industry; Availability.” Federal Register, document no. 2026-21516. Filed October 20, 2026.
https://public-inspection.federalregister.gov/2026-21516.pdf.
(Rh/APC)
