FDA Medical Device User Fees for FY2027: What's Changing

FDA has released its medical device user fees for Fiscal Year 2027. The new rates take effect October 1, 2026, and include increases across establishment registration and common premarket submissions. Annual establishment registration rises from $11,423 to $13,785, an increase of more than 20%. The 510(k) submission fee moves from $26,067 to $28,653, while a De Novo request rises from $173,782 to $191,020, and PMA and other full-fee applications climb from $579,272 to $636,732.

For startups and small manufacturers, these increases compound the importance of getting a submission right the first time. Device classification questions, labeling issues, incomplete UDI data, and missing documentation can all delay a submission. Waiting to identify these gaps leaves less time to resolve them and can push your filing further into the registration period, where you may be exposed to the new, higher fee schedule.

Manufacturers planning a submission near the fiscal year boundary should budget for the FY2027 rates now, confirm their device classification and predicate strategy early, and run a documentation completeness check well ahead of their target filing date. A pre-submission gap assessment is the most reliable way to avoid costly delays and repeat fees under the new, higher rate structure.