Section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 350d] requires food facilities required to register with FDA to renew such registrations during the period beginning on October 1 and ending on December 31 of each even-numbered year.
- If you have registered your food facility before October 1, 2018, you must still renew your registration before December 31, 2018 and provide any updated information, if applicable.
- If you have updated your food facility registration before October 1, 2018, you must still renew your registration before December 31, 2018 and provide us with any updated information, if applicable.
- As a reminder, if you are the new owner of a registered food facility, the previous owner is required to cancel the food facility’s registration within 60 calendar days of the change of ownership and you must re-register the facility reflecting the new ownership (see 21 CFR 1.234 and 1.235).
The owner, operator, or agent in charge of the facility, or a person authorized by one of them, can submit a facility’s registration renewal electronically at https://www.access.fda.gov/. Please note that you must first create or have an existing FURLS account to access the module and submit your renewal.
Alternatively, you may submit your registration renewal via mail or fax using FDA Form 3537.
DOWNLOADÂ FORM FDA 3537.
This year, the abbreviated renewal process is available for facilities that do not have information changes under 21 CFR 1.232 since the submission of the preceding registration, registration renewal, or update (see 21 CFR 1.230(c)). If you use the abbreviated registration renewal process, you must confirm that no changes have been made to the information required under 21 CFR 1.232 since you submitted the preceding registration, registration renewal, or update, and you must certify that the information submitted is truthful and accurate. This option is available on both paper and electronic submissions and must include the submitters name.
Visit https://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/default.htm for more information about food facility registration and the 2018 biennial renewal including guidance documents and user guides for our Food Facility Registration Module (FFRM).
Also beginning October 1st, human food facilities that meet the definition of a “qualified facility” in part 117 and are subject to modified requirements of the preventive control rule will be able to submit the qualified facility attestation forms electronically via the Qualified Facility Attestation Module. For more information, visit the FDA page on qualified facility attestation.
Please contact the FDA Industry Systems Help Desk at [email protected], toll-free in the USA 1-800-216-7331, or 240-247-8804 if you require additional assistance.
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