FDA revises guidance for facility registration

Dec. 28, 2016

The US Food and Drug Administration has made available a draft guidance for industry entitled “Questions and Answers Regarding Food Facility Registration (Seventh Edition): Guidance for Industry.”

This revised publication contains 17 sections of a multi-section guidance intended to provide updated information and answer frequently asked questions regarding FDA registration requirements. The 2016 Food Facility Registration biennial renewal period began October 1 and ended December 31, 2016. Food facilities that manufacture/process, pack or hold food for consumption in the United States are required to register with the FDA.

This revised draft guidance supersedes the version of the food facility registration draft guidance announced November 8, 2016. The revised draft guidance now includes “Who is Exempt from Registration?” and “Definitions,” from the draft guidance. This revised guidance includes an additional question and answer related to mobile facilities in the section titled “What Information is Required in the Registration?”

When completed, this guidance is intended to provide updated information relating to the food facility registration requirements in the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Although you can comment on any guidance at any time, to ensure that the FDA considers your comment on the draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by March 27, 2017.

For more information on the FSMA, go to www.fda.gov/fsma.