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FDA software guidance

FDA finalizes software labeling guidance for drug sponsors

The notice explains which software outputs distributed by sponsors of prescription drugs and drug-led combination products fall under FDA labeling rules.

By Ruth Kaplan, Health systems correspondent
. 1-minute read.
Illustration: FDA guidance Federal Register notice
Illustration: Clinical Observer

The Food and Drug Administration has posted a notice that a final industry guidance, “Regulatory Considerations for Prescription Drug Use-Related Software,” is now available. The document explains how the agency will apply its drug labeling rules to certain software output that a drug sponsor distributes for use with a prescription drug or with a prescription drug-led combination product. The relevant products are those for which the lead center is the Center for Drug Evaluation and Research, or else the Center for Biologics Evaluation and Research.

The Federal Register notice is dated October 21, 2026. The final guidance replaces a draft version with the same title that was issued on September 19, 2023. Comments may be submitted under docket number FDA-2023-D-2482.

FDA accepts comments on guidance documents at any time. Electronic comments can be sent through regulations.gov and will be posted to the docket without changes, so the agency advises commenters not to include confidential information such as medical information, Social Security numbers, or proprietary manufacturing details. Paper comments may be mailed or delivered to the Dockets Management Staff at 5630 Fishers Lane, Room 1061, Rockville, Maryland 20852. Comments that are not marked confidential will be available to the public on regulations.gov or at the dockets office between 9 a.m. and 4 p.m. on weekdays.

For a confidential paper submission, FDA asks for two copies: one copy should carry the heading “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION” and include the confidential material, while the second copy should have that material removed for public viewing. A commenter who does not want a name and contact information made public can put those details on the cover sheet and label them confidential.

Single copies of the guidance can be requested from the Division of Drug Information at the Center for Drug Evaluation and Research, 10001 New Hampshire Avenue, Hillandale Building, 4th Floor, Silver Spring, Maryland 20993-0002; requesters should include a self-addressed adhesive label.

Ruth KaplanHealth systems correspondent

Ruth Kaplan covers hospitals, health systems and the business of care for Clinical Observer. She writes from published reporting, filings and official statements.

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