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  1. FDA User Fee Programs

Accredited Third-Party Certification Program User Fees

FDA’s Accredited Third-Party Certification Program was established under the FDA Food Safety Modernization Act (FSMA). It is a voluntary program that allows “accreditation bodies” to apply for recognition by FDA. Recognized accreditation bodies will have the authority to accredit third-party “certification bodies”, also known as third-party auditors.

FSMA also directs FDA to establish a reimbursement (user fee) program by which FDA assesses fees and requires reimbursement for the work FDA performs to establish and administer the accredited third-party certification program. The user fee rates are calculated each fiscal year and published before the start of a new fiscal year.



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