FDA Extends Registration Deadline
Talk about tidings of great joy—the U.S. Food and Drug Administration (FDA) is giving the world’s medical device manufacturers some additional time to renew their annual registrations with the agency.
Device makers now have until Jan. 31 to register their firms for fiscal year 2013 (which runs from Oct. 1, 2012 through Sept. 30). FDA officials gave medtech manufacturers an additional month (the original deadline was Dec. 31) to register in order to comply with new registration and listing mandates that took effect Oct. 1, 2012.
The new requirements include the following:
• All proprietary names under which a medical device is marketed must be reported, at a minimum, when a device is first listed and during the annual update of registration and listing information;
• All contract manufacturers and sterilization facilities must register and list a device regardless of whether they commercially distribute the product or return the device to the manufacturer or specification developer;
• Initial importers must identify the manufacturers of the medical devices they import;
• Foreign companies that export medical devices or export products to the United States must identify all known U.S. importers of their merchandise;
• All establishments required to register with the FDA must pay the annual registration user fee;
• Each device firm must identify one contact person within the organization who can create a master account in FURLS (FDA Unified Registration and Listing System)
• Organizations that handle only complaints and previously registered as manufacturers or specification developers must change their establishment type to “Complaint File Establishment” and
• Device makers in foreign trade zones must register and list, as well as identify themselves as being located in a foreign trade zone.
The new registration changes also require manufacturers to identify initial importers. The FDA eventually will allow foreign exporters that are not yet shipping products to the United States to register without specifying an importer.