Draft Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Seventh Edition) - Revised


How to Comment
You may submit either electronic or written comments regarding this guidance through March 27, 2017.

Submit Written Comments
Division of Dockets Management (HFA-305),
Food and Drug Administration,
5630 Fishers Lane, rm. 1061,
Rockville, MD 20852

Submit Comments Online
Submit electronic comments on to docket folder FDA-2012-D-1002

For questions regarding this document contact FDA’s Technical Assistance Network by submitting the inquiry form.

Contains Nonbinding Recommendations
Draft - Not for Implementation

December 2016

This revision (Seventh Edition) is being issued as Level 1 draft guidance pursuant to 21 CFR 10.115 and includes additional questions and answers relating to the Amendments to Registration of Food Facilities final rule (Registration Final Rule) (81 FR 45912; July 14, 2016) that revised FDA’s registration regulations and other questions and answers regarding food facility registration.

The new questions and answers are identified with the date that they were added to the guidance. We also revised information in existing questions and answers, deleted some questions and answers, and made editorial changes (e.g., reorganized existing questions and answers) to improve clarity. For the revised questions and answers, we have not added a date indicating when the questions and answers were revised.

The first edition of this document was issued as Level 2 guidance pursuant to Title 21, Code of Federal Regulations (CFR), Section 10.115 (21 CFR 10.115) and was made available on FDA's website on December 4, 2003.

The second, third, fourth, and fifth editions of this document were issued as Level 1 guidance documents pursuant to 21 CFR 10.115 and were made available on FDA’s website on January 12, 2004, February 17, 2004, August 2004, and December 2012, respectively. 

This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the telephone number listed on the title page of this guidance.


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