United States · Food and Drug Administration · Medical devices
Review target
180 days
performance goal
Legal time limit
180 days
regulation
Steps
6
5 requirements
Application fee
$636,732
FY2027
The route for Class III devices, the highest-risk class, that require premarket approval. The application has separate sections on nonclinical laboratory studies and clinical investigations. Some applications go to an advisory panel, which has a longer review goal. Class III devices that require premarket approval.
The official review target is 180 days (performance goal, met in 90% of cases). The legal time limit is 180 days. Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
The pma application fee is $636,732 for FY2027. A reduced fee of $159,183 applies in some cases (Reduced fee for qualifying small businesses. A business with no more than 30 million dollars in gross receipts or sales may get a waiver for its first premarket application).
1. Send the PMA; 2. Acceptance for filing review (15 days); 3. Review (180 days); 4. Major deficiency letter (clock stopped); 5. Advisory panel (if needed) (320 days); 6. Decision.
Outcome: An approval order, or an approvable or not approvable letter.
Legal basis: Section 515 of the Federal Food, Drug, and Cosmetic Act; 21 CFR Part 814
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 515 days end to end with the official step targets. Targets, not actual times.
From the official approvals data of this market, all products of this pathway type and segment
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| Review targetperformance goal, met in 90% of cases. 180 review days for 90 percent of applications without an advisory panel. This is an official target, not an actual review time. | 180 days |
| Legal time limitregulation. The regulation sets 180 days after filing, unless a major amendment is sent. | 180 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| PMA application feeApplication · FY2027 · Reduced fee for qualifying small businesses. A business with no more than 30 million dollars in gross receipts or sales may get a waiver for its first premarket application. | $636,732reduced $159,183 |
| PMA panel-track supplementSupplement · FY2027 · Small business fee | $509,386reduced $127,347 |
Other routes in United States: Premarket notification (510(k)), De Novo classification request, Humanitarian device exemption, 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 (14 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.