United States · Food and Drug Administration · Combination products
Review target
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Not published
Legal time limit
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Not published
Steps
3
1 requirements
Application fee
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A product that combines a drug, a device or a biological product is assigned to one lead center. The lead is set by the primary mode of action, the part expected to make the greatest contribution to the intended effect. A company can ask for a formal designation, and the product then follows that center's premarket route. When it is unclear which center leads the review of a combination product.
1. Send a request for designation; 2. Letter of designation (60 days); 3. Follow the lead center's route.
Outcome: A letter of designation naming the lead center.
Legal basis: Section 503(g) of the Federal Food, Drug, and Cosmetic Act; 21 CFR Part 3
Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).
About 60 days end to end with the official step targets. Targets, not actual times.
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| No time targets published. |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| No fees published. |
Other routes in United States: Premarket notification (510(k)), Breakthrough devices program. See all routes on the United States page or explore them in the Regulatory section.
Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (4 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.