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GUIDANCE DOCUMENT

Regulatory Considerations for Prescription Drug Use-Related Software September 2023

Download the Draft Guidance Document Read the Federal Register Notice
Draft Level 1 Guidance

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2023-D-2482
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research
Center for Devices and Radiological Health
Oncology Center of Excellence

This guidance describes how FDA intends to apply its drug labeling authorities to certain software outputs that are disseminated by or on behalf of a drug sponsor for use with a prescription drug or a prescription drug-led, drug-device combination product (hereafter referred to as a “combination product”) that is assigned to the Center for Drug Evaluation and Research or the Center for Biologics Evaluation and Research as the lead center.  This guidance expands on and was developed in response to comments submitted in response to the Federal Register notice “Prescription Drug-Use-Related Software; Establishment of a Public Docket; Request for Comments" (83 FR 58574 (November 20, 2018)).

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Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2023-D-2482.

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