United States · Food and Drug Administration · Medical devices
Review target
-
Not published
Legal time limit
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Not published
Steps
3
2 requirements
Application fee
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A program for devices that give more effective treatment or diagnosis of life-threatening or irreversibly debilitating conditions, and that are a breakthrough technology, have no cleared or approved alternative, offer significant advantages, or are in the best interest of patients. Designated devices get priority review and closer interaction during development. Devices for life-threatening or irreversibly debilitating conditions that meet one of the added criteria.
1. Request the designation; 2. Decision on the request (60 days); 3. Expedited development and priority review.
Outcome: Designation for expedited development and priority review.
Legal basis: Section 515B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e-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: Combination product: request for designation, Premarket notification (510(k)), De Novo classification request, Premarket approval (PMA), Humanitarian device exemption, Class I devices exempt from premarket notification, Software as a medical device: how it is regulated, Emergency use authorization. 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 (5 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.