RegulatoryGuideline · draft

FDA revises draft guidance on drug delivery device performance characteristics

🇺🇸 FDA · Fri 30 Oct 2026

The agency has reissued its draft guidance on delivery performance information for drug-delivery devices and combination products, replacing the version announced in July 2024.

The US Food and Drug Administration has announced a revised draft guidance for industry titled "Essential Drug Delivery Performance Characteristics for Devices Intended to Deliver Drugs and Biological Products". The notice is dated 30 October 2026.

The revision replaces the earlier draft, "Essential Drug Delivery Outputs Intended to Deliver Drugs and Biological Products", which was announced in the Federal Register on 1 July 2024 (89 FR 54470). The new title shifts the terminology from "outputs" to "performance characteristics".

The guidance covers devices intended to deliver a human drug, including a biological product, as well as combination products that include a device constituent part. The agency refers to these collectively as drug delivery devices.

It offers recommendations on how sponsors should develop and organise device drug-delivery performance information and data. FDA says the aim is to make this information more consistent across applications and to support transparency and predictability in development and regulatory review.

As context, draft guidance documents represent the agency's current thinking for consultation and are not final. The full text of the revised document was not available for this report, so details of the specific recommendations are not covered here.

What it means for your team

  • Teams with drug-device or biologic-device combination products should check the revised draft against any planning based on the 2024 draft, which it replaces.
  • Regulatory affairs staff may want to review how delivery performance data are organised in applications, given FDA's stated goal of greater consistency.
  • Sponsors may wish to read the full text and consider whether to comment through the usual docket process, once the details are confirmed.

Official guideline text: FDA ↗

Article written by VigiEye from the official source (FDA). AI-assisted; check the source before acting.

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