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FURLS is a Food and Drug Administration’s (FDA) Unified Registration and Listing System. It is used by the FDA to help applicants register through the online system and make electronic submissions. FURLS is also used by other centers within the FDA as a system for registration and listing. FURLS allow applicants to view and edit their applications even after submission.

Types of FURLS Accounts

1. Owner/Operator

An owner/operator can be the corporation, company which is affiliated, subsidiary, partner, or proprietor responsible for the registration and listing activities. Any creation of additional identified accounts is the responsibility of the owner/operator.

Responsibilities

  • Creating and updating the FURLS accounts of all the correspondents
  • Assigning official correspondents for registration purpose
  • Creating new registrations and listings
  • Modifying registrations and listings
  • Viewing all the listings as well as the non-exempt listings, which are required to be replaced

2. Official Correspondent

An official designated to carry out the annual registration and listing for an establishment is called as an official correspondent. The official correspondent is appointed by the owner/operator and is responsible for every registration and listing of the establishment.

Responsibilities

  • Creating new registrations and listings
  • Modifying registrations and listings
  • Adding establishments to the previously added listings
  • Viewing all the listings and the registrations

Registration of Company Through the FURLS

  • To register, a company must submit its registration and listings through FDA’s FURLS
  • Owner/operator must have a valid login ID and password to access the FURLS
  • In case of official correspondent, owner/operator are required to create separate sub-account for the correspondent
  • An annual registration can also be obtained for the owner/operator

The FURLS is established by the FDA for the advancement of electronic submissions. To know more about similar global online systems for quick product registrations, reach out to Freyr at sales@freyrsolutions.com.