United States · Food and Drug Administration · Medical devices
Review target
-
Not published
Legal time limit
75 days
regulation
Steps
3
3 requirements
Application fee
-
A route for devices that treat or diagnose diseases or conditions that affect not more than 8,000 people in the United States. The device is exempt from the effectiveness requirements, but its probable benefit to health must outweigh its risks. Devices for very small patient groups.
1. Send the HDE application; 2. Review (75 days); 3. Decision.
Outcome: An approval order, approvable letter, or not approvable letter.
Legal basis: Section 520(m) of the Federal Food, Drug, and Cosmetic Act; 21 CFR Part 814 Subpart H
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 75 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
| Legal time limitregulation. 75 days after an accepted application, if no major amendment is sent. | 75 days |
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), Class I devices exempt from premarket notification, 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 (6 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.