A final rule published in the Federal Register by the US Food and Drug Administration (FDA) on August 2 requires all medical device registration and listing information to be submitted electronically on the FDA Unified Registration and Listing System.
The owner or operator must assign a contact person to create a master account and any subaccounts with the FDA Unified Registration and Listing System (FURLS) and an official correspondent to register any devices. Any foreign establishment registered must also include the name and contact information for its US agent. Foreign companies that re-export devices from a foreign trade zone must also comply with electronic registration requirements.
The FDA states that FURLS will allow the FDA to gather information more effectively concerning marketed devices that might be needed to accomplish statutory and regulatory objectives. “The process of submitting registration and listing information for devices will be more efficient for industry and will provide faster access to this information for both the FDA and industry,” according to the FDA.
All device information submitted prior to Sept. 15, 2007, has already been moved to the FURLS database. The final rule will go into effect on Oct. 1.