Laboratory accreditation for analyses of foods: what you need to know about the FDA regulation : guidance for industry : small entity compliance guide

Laboratory accreditation for analyses of foods: what you need to know about the FDA regulation : guidance for industry : small entity compliance guide

Collection:
Health Policy and Services Research
Contributor(s):
United States. Department of Health and Human Services, issuing body.
United States. Food and Drug Administration, issuing body.
United States. Food and Drug Administration. Office of Regulatory Affairs, issuing body.
Center for Food Safety and Applied Nutrition (U.S.), issuing body.
Center for Veterinary Medicine (U.S.), issuing body.
Publication:
Rockville, MD : Center for Food Safety and Applied Nutrition, October 2022
Language(s):
English
Format:
Text
Subject(s):
Food Analysis -- legislation & jurisprudence
Food Safety
Government Regulation
Laboratories
Legislation, Food
United States
United States. Food and Drug Administration
Genre(s):
Guideline
Technical Report
Abstract:
The FDA Food Safety Modernization Act (FSMA) directs the Food and Drug Administration (FDA) as the food regulatory agency of the U.S. Department of Health and Human Services to better protect public health by, among other things, adopting a modern, preventive, and risk-based approach to food safety regulation. Section 202(a) of FSMA created section 422 of the Federal Food, Drug, and Cosmetic (FD&C) Act, which directs FDA to establish a laboratory accreditation program for the analyses of foods in certain circumstances. More specifically, section 422 of the FD&C Act directs FDA to recognize accreditation bodies that will accredit laboratories to standards established by the Agency. FDA is to maintain a list of accreditation bodies and laboratories participating in the program. In certain circumstances related to food safety and as described in section 422 of the FD&C Act, testing may only be conducted by a laboratory participating in the program. Section 422 of the FD&C Act further provides that the results of tests conducted under the program must generally be sent by the participating laboratory directly to FDA. On December 3, 2021, FDA issued a final rule, “Laboratory Accreditation for Analyses of Food” (86 FR 68728) (the LAAF rule or the rule) to implement section 422 of the FD&C Act. The LAAF rule establishes the Laboratory Accreditation for Analyses of Foods (LAAF) program through regulations at 21 CFR part 1, subpart R (1.1101 through 1.1201). The regulations describe applicable requirements and processes by which accreditation bodies and laboratories may participate in the LAAF program, how FDA will oversee those entities and manage the program, and which food safety-related testing must be conducted by a participating laboratory.
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (19 pages))
Illustrations:
Illustrations
NLM Unique ID:
9918504488406676 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/9918504488406676