Guidance for Industry: U.S. Agent Voluntary Identification System (VIS) for Food Facility Registration

Description

The purpose of this guidance document is to announce that FDA has established a U.S. Agent Voluntary Identification System (VIS) in conjunction with our food facility registration database, the Food Facility Registration Module (FFRM). The purpose of the VIS is to ensure the accuracy of U.S. agent information and enable U.S. agents to independently identify the facility or facilities for which the agent has agreed to serve. This guidance provides information for U.S. agents and foreign facilities importing food into the U.S. who choose to utilize the VIS.

Scope & Applicability

Regulatory Context

• 21CFR1.234§ 1.234 How and when do you update your facility's registration information?

  (a) Update requirements. You must update a facility's registration within 60 calendar days of any change to any of the information previously submitted under § 1.232 (e.g., change of operator, agent in charge, or U.S. agent), except a change of the owner. You may authorize an individual to update a Read full regulation →

• 21CFR1.245§ 1.245 Waiver request.

  Under §§ 1.231(a)(2) and (b) , 1.234(d) , and 1.235(d) , beginning January 4, 2020, you must submit your registration, registration renewal, updates, and cancellations to FDA electronically unless FDA has granted a waiver from such requirement. Under § 1.232(a)(6) , you must provide the email addresRead full regulation →

• 21CFR1.232§ 1.232 What information is required in the registration?

  (a) For a domestic and foreign facility, the following information is required:Read full regulation →

• 21CFR1.231§ 1.231 How and where do you register or renew your registration?

  (a) Electronic registration and registration renewal.Read full regulation →

• Small Entity Compliance Guide: Registration of Food Facilities (Status: Final)
• Draft Guidance for Industry: Questions and Answers on the Accredited Third-Party Certification Program (Status: Draft)
• Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Seventh Edition) (Status: Final)