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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Device types classified in Class I do not need a premarket notification, with exceptions. Class I devices of substantial importance in preventing impairment of health, or with a potential unreasonable risk, still need one. Exempt devices follow the general controls, such as registration and listing. Low-risk device types classified in Class I and not reserved.
1. Confirm the device type is exempt; 2. Register the establishment and list the device; 3. Place on the market under general controls.
Outcome: No premarket review. The device can be sold after registration and listing.
Legal basis: Section 510(l) of the Federal Food, Drug, and Cosmetic Act
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).
Official step durations
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)), De Novo classification request, Premarket approval (PMA), Humanitarian device exemption, Software as a medical device: how it is regulated, Breakthrough devices program, 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 (4 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.