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FDA Issues Final Rule on Records Access, Guidance for Industry

Apr 16, 2014

The Food and Drug Administration has issued a final rule that aligns its regulations on recordkeeping with the agency’s expanded access to records allowed under the Food Safety Modernization Act. The final rule adopts without change the interim final rule that was issued February 2012. 

The rule allows FDA to access records beyond those relating to specific suspect food articles if the agency believes that other foods articles are likely to be affected in a similar way. It also permits FDA to access records relating to other foods where there is a “reasonable probability” that use or exposure to the food will cause serious adverse health consequences or death.

Along with the rule, FDA issued two guidance documents and will accept comments from industry before making them final. The first, “FDA Records Access Authority Under Sections 414 and 704 of the Federal Food, Drug, & Cosmetic Act,” includes minor changes to draft guidance that was issued in 2012. The second, “What You Need to Know About Establishment, Maintenance and Availability of Records; Small Entity Compliance Guide,” updates FDA’s previous guide issued in 2004.

In May 2012, IDFA filed comments regarding the draft guidance, asking for clarifications that would provide safeguards for due process, ensure consistency and contain the requests to documents that are relevant.

Read the documents here.

 For more information, contact Clay Detlefsen, IDFA vice president of regulatory affairs, at

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