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Product safetyFDAUnited StatesImports

Essential Drug Delivery Performance Characteristics for Devices Intended To Deliver Drugs and Biological Products; Revised Draft Guidance for Industry; Availability

30 October 2026

In plain English

FDA announces a revised draft guidance, replacing the July 1, 2024 draft, on essential drug delivery performance characteristics for devices delivering drugs and biological products.

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Topic
Product safety
Regulator
FDA
Published
30 October 2026
For
Imports
Where it applies
United States
Source
FDA (Food and Drug Administration)

From the notice

The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled "Essential Drug Delivery Performance Characteristics for Devices Intended to Deliver Drugs and Biological Products." This revised draft guidance revises and replaces the draft guidance entitled "Essential Drug Delivery Outputs Intended to Deliver Drugs and Biological Products" announced in the Federal Register on July 1, 2024 (89 FR 54470). In accordance with its m
The full text is at the source

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