ANAB is recognized by the U.S. Food and Drug Administration (FDA) as an accreditation body under the Food Safety Modernization Act (FSMA) Accredited Third-Party Certification Program.
The FSMA Final Rule on Accredited Third-Party Certification establishes requirements for accreditation of third-party CBs. FSMA certifications issued under the U.S. Food and Drug Administration (FDA) third-party program are used:
- By importers for establishing eligibility of foreign suppliers for expedited review of food entry in the United States.
- For supplier verification activities under the Food Safety Verification Program and Preventive Controls rules.
- When required by FDA as a condition of entry under specific circumstances related to safety risks.
See the FDA website for compliance date of the Food Safety Verification Program.
Through the ANAB accreditation process, CBs can demonstrate conformance with and implementation of the requirements that meet stipulations under FDA's accredited third-party certification program. ANAB's program provides credibility by incorporating the requirements of ISO/IEC 17021-1 as base requirements for this program.
Please refer to the information about the accreditation process at How to Become an ANAB-Accredited Certification Body.
Accreditation oversight can be combined with any of ANAB's existing accreditation programs.
You can view the FDA FSMA application in .pdf format to understand specific requirements but the application process must be completed online via ANAB's EQM database; first-time EQM users must register to create an account.
Accreditation Requirements for Management Systems CBs
ANAB Accreditation Rule 55
CL 5316, FDA FSMA Supplemental Requirements Matrix
There are various FDA requirements for accreditation bodies to make information publicly available, including but not limited to accreditation status and information on the dates that accredited CB fees are paid. This page will be under construction until ANAB achieves FDA recognition and CBs begin the accreditation process with ANAB.
CB Fee Payments
CB Scope Reductions
For more information, contact Natalia Larrimer at firstname.lastname@example.org.
More information: Key Facts About the Accredited Third-Party Certification Program