FDA prescription drug use-related software guidance finalized

FDA prescription drug use-related software guidance is now final

The FDA prescription drug use-related software guidance is final, dated October 2026, with a notice of availability published October 21, 2026 (FR Doc. 2026-21516). Sponsors use it when a companion app is disseminated with a prescription drug. End-user output from that software is prescription drug labeling: FDA-required labeling reflected in the prescribing information (PI), or promotional labeling submitted on Form FDA 2253.

The final text replaces the September 19, 2023 draft. FDA lists it as a Final Level 1 Guidance under docket FDA-2023-D-2482 on its guidance page.

What counts as prescription drug use-related software (PDURS)

The guidance defines prescription drug use-related software (PDURS) as software that "(1) is disseminated by or on behalf of a drug sponsor and (2) 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 under the FD&C Act."

End-user output is any content the software presents to the end user, for example a patient, caregiver or health care practitioner. That includes static or dynamic screen displays, and sounds or audio messages. FDA treats all of that output as prescription drug labeling.

It applies to sponsors of prescription drugs, and of prescription drug-led combination products where CDER or CBER is the lead center. "On behalf of" can include a software developer working under an agreement with the drug company that distributes the app or directs users to it. Software no sponsor disseminates is outside the guidance, even if the developer intends it for use with a drug. Output that is entirely about the disease state, and not specific to the sponsor's drug, generally falls outside PDURS too.

A device-connected function relies on data from the device or device constituent part of a combination product. A standalone function is any other function, such as one that uses data the user types in. Those labels describe data source and connectivity, not whether the function is under device oversight.

Prescribing information or promotional labeling

FDA uses these factors to sort the output, and to decide whether the function is described in the PI (PDF):

• whether the software is essential to the safe and effective use of the product
• whether sponsor evidence shows a meaningful improvement in a clinical outcome when the software is used with the drug
• whether the software relies on data from a device or device constituent part

If the software is necessary for safe and effective use, the output generally is FDA-required labeling. Where and how the software is described in the PI is decided during FDA review.

Sponsors can also show a meaningful improvement versus use of the drug without the software, in one or more adequate and well-controlled studies under 21 CFR 314.126(b). Those studies can use real-world data where appropriate, and a validated surrogate endpoint can count. If FDA agrees, the output generally is FDA-required labeling. FDA generally recommends describing the studies and their results in the CLINICAL STUDIES section of the PI. If the software is not necessary for safe and effective use, and FDA has not found a meaningful improvement in a clinical outcome, the function type sets what the PI says:

Appendix A is a decision tree for that labeling call. Appendix B gives sample PI wording for a device-connected function. Appendix C gives a sample CLINICAL STUDIES entry for a standalone diabetes app used with an oral drug, where the evidence shows a meaningful clinical improvement (HbA1c in the example).

Form FDA 2253 and app updates

Promotional end-user output, and updates to it, go to FDA on Form FDA 2253 at the time of initial dissemination, under 21 CFR 314.81(b)(3)(i) and 601.12(f)(4). The form has a "PDURS" material type. Accelerated-approval products follow pre-dissemination submission rules under 21 CFR 314.550 and 601.45. Sponsors can ask for voluntary comment before use under 21 CFR 202.1(j)(4), from OPDP for CDER products or from CBER's APLB. The guidance's recommendations are non-binding, but the Form FDA 2253 duty, where it applies, comes from the regulations it cites.

Changes to FDA-required output follow the same labeling-change rules as other FDA-required labeling. Some post-approval changes need FDA review and approval under 21 CFR 314.70 and 601.12. Some information must be reported in the annual report.

Software updates that leave previously submitted output unchanged don't require resubmission of that output. FDA's examples are certain security patches and operating system changes. FDA also recommends talking with the CDER or CBER review division early about evidence plans, and about a new or significantly modified device-connected function used with a new or modified device constituent part.

Device rules still apply

The guidance doesn't change the device framework. Whether a software function is a device sits outside its scope. FDA points sponsors to CDRH digital health policies for that assessment.

When a function takes data from a device constituent part, FDA assesses whether the combination product and software accurately and reliably provide data, run analyses and display output. That check applies whether the output is required or promotional labeling. The function should not be expected to cause medication errors, such as extra doses.

Some functions need a PMA, 510(k) or De Novo. CDRH reviews those submissions and consults CDER or CBER. As FDA states, "Form FDA 2253 is not a replacement for a device marketing submission."

What changed from the 2023 draft

FDA's notice lists these changes from the September 2023 draft:

• clearer considerations for standalone software functions
• a decision tree for labeling determinations
• illustrative PI language for device-connected and standalone software
• a recommended PI statement when a device-connected function has no meaningful improvement in a clinical outcome
• editorial changes

RegAffairs AI's answer on whether FDA has finalized its companion app guidance links the FDA sources it used. The final PDF still uses the draft's media URL. Check the cover date, October 2026, before you quote a saved copy.