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.
- Federal Register Notice: Third-Party Certification Program User Fee Rate for Fiscal Year 2020
- Federal Register Notice: Third-Party Certification Program User Fee Rate for Fiscal Year 2019
- Accredited Third-Party Certification Program
- Public Registry of Recognized Accreditation Bodies
- Public Registry of Accredited Third-Party Certification Bodies