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GUIDANCE DOCUMENT

Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products Draft Guidance for Industry June 2024

Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

Submit Comments by

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

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-2024-D-2560


Docket Number:
FDA-2024-D-2560
Issued by:
Guidance Issuing Office
Office of the Commissioner, Office of Clinical Policy and Programs, Office of Combination Products
Center for Biologics Evaluation and Research
Center for Devices and Radiological Health
Center for Drug Evaluation and Research

This guidance addresses key aspects of drug delivery performance information for devices, and combination products that include device constituent parts, intended for delivery of a human drug, including a biological product. The guidance describes FDA’s recommendations related to the device design outputs that are essential for establishing and assessing drug delivery performance. The guidance includes recommendations for the information and data to submit in investigational, marketing, and post-market change applications.

Questions?

Contact Point
Combination Products Guidance Contact
Office of Combination Products
combination@fda.gov
301-796-8930
301-847-8619
 
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