FDA Issues Draft Guidance on Essential Drug Delivery Performance Characteristics for Combination Products

A new FDA draft guidance sets out what device and combination product sponsors must document to establish drug delivery performance, and QA directors and regulatory affairs leads have until 28 January 2027 to shape the final version. The guidance, issued jointly by the Office of Combination Products, CDER, CBER, and CDRH, covers devices and combination products with device constituent parts intended to deliver human drugs and biological products.

The document defines the information and data FDA considers essential for establishing and assessing drug delivery performance across three distinct submission types: investigational applications, marketing applications, and post-market change applications. For regulatory teams managing combination product portfolios, that three-tier scope means documentation strategies will need to be aligned well before a submission reaches the agency, not retrofitted during review.

For QA leads, the cross-center authorship is a signal worth noting. Guidance co-issued by CDER, CBER, and CDRH simultaneously reflects the agency's intent to apply consistent evidentiary standards regardless of which center holds primary jurisdiction over a given combination product. Teams operating under 21 CFR Part 3 designation frameworks should audit current device constituent part characterisation packages against the draft's recommendations now, while the comment window remains open.

The docket number is FDA-2024-D-2560. Comments can be submitted electronically or mailed to Dockets Management, FDA, 5630 Fishers Lane, Rm 1061, Rockville, MD 20852. The Office of Combination Products contact for questions is [email protected], reachable at 301-796-8930.

Sponsors with pending or planned investigational or marketing submissions for drug-device combination products should treat the January 2027 comment deadline as a hard checkpoint for internal gap assessments against the draft's data requirements.

Source: FDA Office of Combination Products / CDER / CBER / CDRH via FDA Guidance Documents RSS Feed, 29 October 2026.