FDA Offers Guidance for Software That Helps People Use Prescription Drugs
Published Date: 10/21/2026
Notice
Summary
The FDA just released new rules about software that helps people use prescription drugs safely. If you make or work with these drug-related apps or software, you’ll need to follow these updated guidelines starting now. This helps keep drug info clear and safe without costing extra money or causing delays.
Analyzed Economic Effects
4 provisions identified: 2 benefits, 2 costs, 0 mixed.
Prescribing Information Must Describe Software
If you are a drug sponsor or developer, the guidance clarifies how the FDA-required Prescribing Information (PI) should describe prescription drug use-related software functions. The final guidance (published October 21, 2026) also recommends adding a PI statement for device-connected software functions for which there is no meaningful improvement in clinical outcome.
When Sponsors Must Submit Software Output
The guidance explains when and how sponsors should submit prescription drug use-related software end-user output to FDA for review. It applies to software outputs that supplement, explain, or are textually related to a sponsor's prescription drug products, per the final guidance announced October 21, 2026.
Software Outputs Treated as Drug Labeling
The FDA says end-user output from prescription drug use-related software is a form of prescription drug labeling when the software is disseminated by or on behalf of a drug sponsor. This applies to outputs presented to patients, caregivers, or health care practitioners and is part of the final guidance announced on October 21, 2026.
Guidance Adds Decision Tree and Examples
The final guidance introduces a decision tree, clarifies considerations for standalone software functions, and provides illustrative Prescribing Information language for device-connected and standalone software. These materials are included in the final guidance issued on October 21, 2026 to help sponsors make labeling determinations.
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