On August 2, the U.S. Food and Drug Administration (FDA) published a final rule in the Federal Register that requires medical device end-product and contract manufacturers to register their products electronically on the FDA Unified Registration and Listing System (FURLS). Each medical device manufacturer, both foreign and domestic, will have to establish an account on the FURLS, which will be used to update information regarding its device establishment registration and device listing information.
The rule also eliminates an existing exemption that foreign companies that re-export devices from a foreign trade zone didn’t have to comply with electronic registration requirements.
The FDA said, among other things, this final rule is designed to do the following:
- 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.
- The FURLS will allow FDA to gather information more effectively concerning marketed devices that might be needed to accomplish statutory and regulatory objectives.
Information submitted prior to September 15, 2007, has been migrated to the FURL database. The final rule will go into effect on October 1, 2012.
