Date: 21-Oct-2026
Agency: USFDA
Intelligence Overview
The U.S. Food and Drug Administration (USFDA) has issued the guidance document Regulatory Considerations for Prescription Drug Use-Related Software: Guidance for Industry. Developed collaboratively by the Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH), Office of Combination Products (OCP), and Oncology Center of Excellence (OCE), the guidance explains how FDA drug-labeling authorities apply to software outputs associated with prescription drug products and certain drug-device combination products.
Prescription drug use-related software includes software distributed by or on behalf of a drug sponsor that provides information supplementing, explaining, or otherwise relating to a prescription drug. Examples include mobile applications that support medication administration tracking, provide dosing recommendations, help monitor treatment response, or assist with managing side effects.
The guidance outlines FDA’s approach to evaluating software-generated information presented to patients, caregivers, and healthcare professionals, particularly when determining whether such information constitutes prescription drug labeling.
Key Highlights
1. Regulatory Classification of Software Outputs
FDA considers software-generated end-user content, including screen displays and audio messages, a type of prescription drug labeling when it falls within the guidance’s scope. Depending on the circumstances, this content may be classified as FDA-required labeling or promotional labeling.
2. Device-Connected and Standalone Software
The guidance distinguishes between device-connected software, which relies on data transferred directly from a device or device constituent part, and standalone software, which may rely on user-entered information. These distinctions influence how sponsors should describe the software in prescribing information.
3. Inclusion in Prescribing Information
The document provides recommendations on when and where software functions should be described in prescribing information. Considerations include whether the software is essential for the safe and effective use of the drug, whether evidence demonstrates a meaningful improvement in clinical outcomes, and whether the software relies on device-generated data.
4. Evidence Supporting Clinical Benefits
Sponsors seeking to demonstrate that software improves clinical outcomes should provide appropriate supporting evidence. The guidance recommends early discussions with the relevant FDA review division regarding study design and the evidence needed to support inclusion of software-related claims in prescribing information.
5. Submission and Post-Approval Considerations
The guidance discusses when and how sponsors should submit software-generated outputs to FDA. It also addresses regulatory considerations for changes to software outputs that constitute FDA-required labeling, including applicable post-approval submission and review procedures.
Regulatory Impact
This guidance highlights the growing importance of integrating digital health technologies into pharmaceutical product development and lifecycle management. Drug sponsors developing prescription drug-related software should assess labeling implications early, establish appropriate evidence-generation strategies, and evaluate applicable submission requirements.
Regulatory affairs, clinical development, labeling, digital health, and combination-product teams may benefit from coordinated planning to ensure that software-related information is accurate, appropriately supported, and consistent with the product’s approved prescribing information.
Important Considerations
The guidance reflects FDA’s current thinking and contains nonbinding recommendations. It focuses on the application of drug-labeling authorities to software outputs and does not independently determine whether a software function meets the definition of a medical device or whether separate device requirements apply.
Sponsors should consult the relevant FDA review division when clarification is needed for specific development programs.
Source: https://www.fda.gov/media/172165/download https://www.fda.gov/regulatory-information/search-fda-guidance-documents/regulatory-considerations-prescription-drug-use-related-software