FSMA Third-Party Certifiers Face 2027 FDA Fee Hikes
Published Date: 7/30/2026
Notice
Summary
The Food and Drug Administration (FDA or we) is announcing the fiscal year (FY) 2027 annual fee rate for recognized accreditation bodies and accredited certification bodies, and the initial and renewal fee rate for accreditation bodies applying to be recognized in the third-party certification program authorized by the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the FDA Food Safety Modernization Act (FSMA). We are also announcing the fee rate for certification bodies applying for direct FDA accreditation.
Analyzed Economic Effects
8 provisions identified: 0 benefits, 8 costs, 0 mixed.
Hourly Work Rates for FY2027 Set
The FDA set the FY2027 fully supported cost per direct work hour at $325 for work that does not require travel and $414 per hour when travel is required. These hourly rates apply from October 1, 2026, through September 30, 2027, and are used to calculate program fees.
Accreditation Body Initial Application Fee
An accreditation body applying for FDA recognition must pay an initial application fee of $56,272. The application fee must be submitted with the application and covers FDA's review and onsite evaluation costs for FY2027 (Oct 1, 2026–Sep 30, 2027).
Annual Fee for Recognized Accreditation Bodies
A recognized accreditation body will be invoiced an annual fee of $2,612 for FY2027 (Oct 1, 2026–Sep 30, 2027). FDA will send annual invoices and payments must be made within 30 days of the invoice date.
Annual Fee for Accredited Certification Bodies
A certification body accredited by a recognized accreditation body must pay an annual fee of $3,266 for FY2027 (Oct 1, 2026–Sep 30, 2027). FDA will send annual invoices and requires payment within 30 days of the invoice date.
Certification Body Direct Accreditation Fee $56,272
A certification body applying for direct FDA accreditation must pay an initial application fee of $56,272 for FY2027. The fee covers FDA review, onsite performance evaluation, and report preparation for the period Oct 1, 2026–Sep 30, 2027.
Accreditation Body Renewal Application Fee
A recognized accreditation body applying for renewal must pay a renewal application fee of $34,311 for FY2027. FDA estimates this covers review, onsite evaluation, and report preparation for renewal applications during Oct 1, 2026–Sep 30, 2027.
Estimated Fees for Directly Accredited Certification Bodies
For certification bodies that would be directly accredited by FDA, FDA estimates a renewal application fee of $34,311 and an annual fee of $26,960 for FY2027. These figures are estimates provided for planning purposes for Oct 1, 2026–Sep 30, 2027.
Payment Rules and Consequences for Nonpayment
Payments must be made within 30 days of the invoice date in U.S. dollars by ACH, credit card (balances under $25,000), or wire transfer. If a recognized accreditation body or accredited certification body fails to pay within 30 days, FDA will suspend recognition or accreditation; failure to pay within 90 days will result in revocation or withdrawal.
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