FDA Updates Guidance on Devices That Deliver Medicines
Published Date: 10/30/2026
Notice
Summary
The FDA just released an updated draft guide to help companies make drug delivery devices, like inhalers or injectors, work better and be easier to review. This affects anyone developing devices that deliver medicines or biological products, aiming to make the process smoother and clearer. Comments on this draft are open until January 28, 2027, so get your feedback in to help shape the final rules!
Analyzed Economic Effects
4 provisions identified: 4 benefits, 0 costs, 0 mixed.
Streamlines drug‑delivery device submissions
If you develop devices that deliver drugs or biological products, FDA's revised draft guidance gives recommendations about the information and data to include in investigational, marketing, and post‑market change applications to improve consistency and facilitate transparency and predictability in regulatory review. The guidance is intended to facilitate and streamline development and lifecycle management of drug delivery devices and revises and replaces the draft guidance announced July 1, 2024 (89 FR 54470).
Clarifies testing and quality system alignment
The revised draft guidance clarifies content on testing and controlling device drug‑delivery performance and indicates alignment with the revised Quality Management System Regulation, 21 CFR part 820. It provides FDA recommendations related to information essential for establishing and assessing device drug‑delivery performance.
No new paperwork collections required
The revised draft guidance states it contains no new collection of information and so Office of Management and Budget (OMB) clearance under the Paperwork Reduction Act is not required. The guidance refers to existing OMB‑approved collections with control numbers such as 0910-0014, 0910-0078, 0910-0001, 0910-0338, 0910-0718, 0910-0231, 0910-0120, 0910-0844, 0910-0139, 0910-0073, 0910-0727, and 0910-0756.
Guidance is non‑binding; alternatives allowed
FDA states the revised draft guidance, when finalized, will represent the Agency's current thinking but does not establish any rights and is not binding on FDA or the public. You may use an alternative approach if it satisfies applicable statutes and regulations.
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