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NewsRegulatoryFDA

FDA Small Entity Compliance Guide for LAAF Program

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Credit: U.S. Food and Drug Administration (FDA)

October 19, 2022

To help small entities participate in or comply with the Laboratory Accreditation for Analyses of Foods (LAAF) program, the U.S. Food and Drug Administration (FDA) has published a guidance. In addition to the Small Entity Compliance Guide, FDA has provided other resources regarding the LAAF program in recent months, including a dashboard and answers to frequently asked questions (FAQs).

Under the LAAF program, recognized accreditation bodies may accredit laboratories to the standards established in the LAAF rule. The LAAF final rule, issued by FDA on December 3, 2021 to fulfill Food Safety and Modernization Act (FSMA) requirements, establishes the LAAF program and outlines eligibility requirements for accreditation bodies and laboratories that wish to participate in the program.

The Small Entity Compliance Guide was prepared in accordance with Section 212 of the Small Business Regulatory Enforcement Fairness Act. The guidance includes a diagram illustrating the structure of the LAAF program, detailed answers to FAQs, LAAF definitions, and LAAF resources.

FDA will also hold an informational webinar on Thursday, October 27, 2022, from 1:00–2:30 P.M. ET on the LAAF program.

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KEYWORDS: compliance FDA guidance LAAF laboratory accreditation

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