08/14/2026
FDA has announced its medical device user fees for Fiscal Year 2027. Preparing for the new rates involves more than updating your regulatory budget.
Whether your company is renewing an establishment registration or preparing a 510(k), De Novo request, PMA, or another submission, now is the time to confirm:
• Which fee and filing requirements apply
• Whether classifications, product codes, and submission details are accurate
• Whether labels, UDI/GUDID data, device listings, and supporting documentation are complete
Registrar Corp’s FY 2027 guide explains the new fees, who may be affected, and what medical device companies can begin reviewing now.
Read the guide: https://hubs.li/Q04sZCKB0
FDA Announces New Medical Device User Fees for FY 2027 beginning October 1, 2026. Compare registration, 510(k), De Novo, and PMA fees.