Key Takeaways
- • On October 20, 2026, the FDA announced final guidance titled "Regulatory Considerations for Prescription Drug Use-Related Software," setting out how the agency will apply drug labeling authorities to software outputs used with prescription drugs and drug-device combination products.
- • The guidance finalizes the September 2023 draft and formalizes "standalone" software functions, defined as any function not device-connected, such as functions relying on user-entered data.
- • Standalone software generally should not be described in the Prescribing Information (PI) unless it is necessary for safe and effective use or sufficient evidence shows a meaningful improvement in a clinical outcome; otherwise, the output is generally promotional labeling.
- • FDA added Appendix A, a four-question labeling decision tree, and Appendices B and C with illustrative PI language for device-connected and standalone software.
- • FDA recommends a PI statement that software is not necessary for safe and effective use where applicable, and encourages sponsors to engage the relevant review division early when generating clinical evidence.
Summary
On October 20, 2026, the Food and Drug Administration (FDA) announced final guidance titled Regulatory Considerations for Prescription Drug Use-Related Software. The guidance sets out how the agency intends to apply its drug labeling authorities to certain software outputs used with prescription drug products and drug-device combination products. It follows the agency's September 2023 draft guidance and a 2018 Federal Register notice requesting comments. The guidance is directed at drug sponsors offering or planning to offer companion software, such as apps connected to a medical device or standalone apps, and at developers of such tools.
The guidance addresses "prescription drug use-related software" (PDURS), meaning software disseminated by or on behalf of a drug sponsor that produces "end-user output" textually related to the sponsor's drugs. FDA treats end-user output as a form of prescription drug labeling even where the software is not regulated as a medical device. The guidance clarifies when end-user output is FDA-required labeling versus promotional labeling, when and how software should be described in the Prescribing Information (PI), and when sponsors should submit end-user output to FDA. In its press release, FDA characterized the approach as reflecting "risk-proportionate oversight" of digital health.
According to the Federal Register notice, FDA made four substantive changes from the draft. First, it formalized the term "standalone" for software functions that are not device-connected. Standalone functions generally should not appear in the PI unless they are necessary for safe and effective use or sufficient evidence shows a meaningful improvement in a clinical outcome. Merely distributing an app alongside a drug does not by itself warrant PI inclusion. Second, FDA added Appendix A, a four-question decision tree addressing CDER/CBER product assignment, sponsor dissemination, whether output is essential or demonstrates clinical benefit, and whether device-connected functions are present. Outcomes include FDA-required labeling with PI description, promotional labeling with PI description, or promotional labeling with no PI mention. FDA cautions that device-related requirements may still apply.
Third, FDA added illustrative PI language. Appendix B covers device-connected software without evidence of clinical improvement, using a hypothetical insulin autoinjector that transmits dosing data to a mobile app; the output is treated as promotional labeling submitted on Form FDA 2253 at initial dissemination. Appendix C covers standalone software supported by adequate and well-controlled studies, using a hypothetical app for a type 2 diabetes drug; where such studies show meaningful clinical improvement, FDA generally recommends describing the evidence in the Clinical Studies section, and the output becomes FDA-required labeling subject to FDA review of certain post-approval changes. Fourth, FDA recommends that, regardless of clinical evidence, PI statements disclose when software is not necessary for safe and effective use, with the example "Use of the associated mobile app is not necessary for safe and effective use of DRUG-X."
FDA recommends that sponsors evaluate whether software is device-connected or standalone, whether it is necessary for safe and effective use, what clinical evidence supports any claimed benefit, and whether resulting content is FDA-required or promotional labeling, including any Form FDA 2253 obligations. The agency specifically advises early engagement with the relevant review division when generating evidence for inclusion of software information in FDA-required labeling.
The guidance addresses "prescription drug use-related software" (PDURS), meaning software disseminated by or on behalf of a drug sponsor that produces "end-user output" textually related to the sponsor's drugs. FDA treats end-user output as a form of prescription drug labeling even where the software is not regulated as a medical device. The guidance clarifies when end-user output is FDA-required labeling versus promotional labeling, when and how software should be described in the Prescribing Information (PI), and when sponsors should submit end-user output to FDA. In its press release, FDA characterized the approach as reflecting "risk-proportionate oversight" of digital health.
According to the Federal Register notice, FDA made four substantive changes from the draft. First, it formalized the term "standalone" for software functions that are not device-connected. Standalone functions generally should not appear in the PI unless they are necessary for safe and effective use or sufficient evidence shows a meaningful improvement in a clinical outcome. Merely distributing an app alongside a drug does not by itself warrant PI inclusion. Second, FDA added Appendix A, a four-question decision tree addressing CDER/CBER product assignment, sponsor dissemination, whether output is essential or demonstrates clinical benefit, and whether device-connected functions are present. Outcomes include FDA-required labeling with PI description, promotional labeling with PI description, or promotional labeling with no PI mention. FDA cautions that device-related requirements may still apply.
Third, FDA added illustrative PI language. Appendix B covers device-connected software without evidence of clinical improvement, using a hypothetical insulin autoinjector that transmits dosing data to a mobile app; the output is treated as promotional labeling submitted on Form FDA 2253 at initial dissemination. Appendix C covers standalone software supported by adequate and well-controlled studies, using a hypothetical app for a type 2 diabetes drug; where such studies show meaningful clinical improvement, FDA generally recommends describing the evidence in the Clinical Studies section, and the output becomes FDA-required labeling subject to FDA review of certain post-approval changes. Fourth, FDA recommends that, regardless of clinical evidence, PI statements disclose when software is not necessary for safe and effective use, with the example "Use of the associated mobile app is not necessary for safe and effective use of DRUG-X."
FDA recommends that sponsors evaluate whether software is device-connected or standalone, whether it is necessary for safe and effective use, what clinical evidence supports any claimed benefit, and whether resulting content is FDA-required or promotional labeling, including any Form FDA 2253 obligations. The agency specifically advises early engagement with the relevant review division when generating evidence for inclusion of software information in FDA-required labeling.
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