FDA Issues Recordkeeping Rule and Guidance for Industry

The U.S. Food and Drug Administration (FDA) has issued a final rule adopting the interim final rule titled “Establishment, Maintenance, and Availability of Records: Amendment to Record Availability Requirements” for recordkeeping regulations under the Food Safety Modernization Act (FSMA). The amendments made under FSMA allow FDA access to records beyond those relating to specific suspect food articles if the agency believes that other food articles are likely to be affected in a similar manner. The amendments also permit FDA to access records relating to articles of food “for which there is a reasonable probability that the use of, or exposure to, the article of food will cause serious adverse health consequences or death to humans or animals.” The expanded records-access authority is intended to improve FDA’s ability to respond to and contain safety problems with the food supply for humans and animals.

FDA has also issued two guidance documents, “FDA Records Access Authority under Sections 414 and 704 of the Federal Food, Drug, &
Cosmetic Act” and “What You Need to Know About Establishment, Maintenance, and Availability of Records—Small Entity Compliance Guide,” which update previous versions. Comments on the guidance documents will be accepted at any time. See Federal Register, April 4, 2014.

Issue 520