FDA finalises guidance treating drug-companion software as drug labelling

The Food and Drug Administration has finalised guidance that treats the software companies send out alongside a prescription drug — the apps, trackers and tools that explain or support the medicine — as a form of drug labelling. The agency announced the guidance's availability in the Federal Register on 21 October 2026 [s1]. It finalises a draft of the same title the FDA issued on 19 September 2023 [s1].

What the guidance covers

The document applies to what the FDA calls "prescription drug use-related software": software that is "disseminated by or on behalf of a drug sponsor" for use with a prescription drug, or with a drug-led, drug-device combination product, that is assigned to the Center for Drug Evaluation and Research or the Center for Biologics Evaluation and Research as the lead centre [s1]. In the agency's framing, such software "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 device" [s1].

The central move is in that last clause. The FDA says it "considers end-user output to be a type of prescription drug labeling" [s1]. End-user output is "any material (content) that the prescription drug use-related software presents to the end user (e.g., a patient, caregiver, or health care practitioner)" [s1]. Classifying that output as labelling matters because labelling is territory the agency already governs tightly: the same rules on accuracy, balance and the presentation of risk that apply to a paper package insert now attach to what an app tells a patient on screen.

The guidance sets out to clarify three things: how the FDA intends to apply its drug-labelling authorities to that end-user output; how the FDA-required labelling, "in particular the Prescribing Information (PI)," should describe the software's functions; and "when and how sponsors should submit end-user output to FDA for review" [s1]. The agency says the recommendations are meant to "align with ongoing Agency initiatives across all product centers, including digital health initiatives at the Center for Devices and Radiological Health," so that software reviewed as a device is handled consistently [s1].

What changed from the 2023 draft

The FDA says it "considered comments received on the draft guidance as the guidance was finalized" and lists four substantive changes [s1]. It clarified "the considerations for standalone software functions"; introduced "a decision tree to guide sponsors through labeling determinations"; added "illustrative examples of PI language for both device-connected software and standalone software"; and now recommends "the addition of a statement in the PI for device-connected software functions for which there is no meaningful improvement in a clinical outcome" [s1]. The rest, the agency says, were editorial changes "to improve clarity" [s1].

That last addition is the most pointed for readers. Software bundled with a drug can imply a clinical benefit — better adherence, tighter monitoring, improved outcomes — that has not actually been demonstrated. The recommended PI statement is aimed squarely at that gap, so the prescribing information flags when a connected tool has not been shown to improve a clinical result.

What it does and does not do

The guidance is not a regulation. The FDA issued it under its good guidance practices rule, 21 CFR 10.115, and states plainly that it "represents the current thinking of FDA," "does not establish any rights for any person and is not binding on FDA or the public" [s1]. Sponsors "can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations" [s1]. In other words, it signals how the agency intends to read its existing labelling authorities when drug-companion software is involved, rather than creating new legal obligations.

The agency also recorded that it "considered the applicability of Executive Order 14192" — the administration's deregulatory order — and found the action to be "neither an E.O. 14192 regulatory action nor an E.O. 14192 deregulatory action" [s1]. The guidance "contains no collection of information," though it refers to previously approved FDA collections under the Paperwork Reduction Act [s1].

What to watch

Because guidance is non-binding, its force depends on how the FDA applies it in review and how sponsors respond. The practical test will be whether the decision tree and the illustrative PI language give companies enough certainty to build and submit drug-companion software without guessing how the agency will treat it, and whether the recommended "no meaningful improvement" statement actually appears in prescribing information for connected tools that lack outcome data. Comments may be submitted at any time under docket FDA-2023-D-2482, and the final guidance is posted on the FDA's guidance pages and at regulations.gov [s1][s2].