GUIDANCE DOCUMENT
Regulatory Considerations for Prescription Drug Use-Related Software September 2023
Not for implementation. Contains non-binding recommendations.
This guidance is being distributed for comment purposes only.
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All written comments should be identified with this document's docket number: FDA-2023-D-2482
- Docket Number:
- FDA-2023-D-2482
- Issued by:
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Guidance Issuing OfficeCenter for Drug Evaluation and ResearchCenter for Biologics Evaluation and ResearchCenter for Devices and Radiological HealthOncology 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)).