US FDA · Draft guidance
FDA consults on essential drug-delivery performance characteristics
Official source date: · Source checked
Draft guidance addresses performance information for drug-delivery devices and combination products, including evidence for investigational, marketing and post-market change submissions. The FDA page lists 28 January 2027 for comments.
Who should review this?
Drug-delivery device, combination-product, engineering, quality and regulatory teams.
What it means for pharmaceutical teams
The proposed recommendations concern information used to establish and assess drug-delivery performance. Review should distinguish the device or combination-product scope from requirements for unrelated manufacturing equipment.
Practical review checklist
PharmaEdges reading prompts for your own applicability review:
- Compare the draft scope with your product and planned submissions.
- Discuss relevant performance evidence with engineering and regulatory colleagues.
- Check the FDA docket and comment instructions before submitting feedback.
Official source and verification
Read the US FDA source (opens in a new tab)
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