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The U.S. Food and Drug Administration (FDA) today issued a final rule, "Establishment, Maintenance, and Availability of Records: Amendment to Record Availability Requirements," as well as two Guidance for Industry documents to help food companies comply with the regulation.
The Guidances are entitled “What You Need To Know About Establishment, Maintenance, and Availability of Records—Small Entity Compliance Guide” (Docket No. FDA-2013-N-1421) and "FDA Records Access Authority Under Sections 414 and 704 of the Federal Food, Drug, & Cosmetic Act" (Docket No. FDA-2011-D-0674-0044). The FDA is accepting comments on both documents, electronically via Regulations.gov or in writing to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.
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