FDA Wants Medical|Devices E-Registered

WASHINGTON (CN) - The FDA plans to require that medical devices be registered in an electronic Internet based system that the agency would use to track recalls, inspections and illegal marketing, and identify establishments that may have needed devices for a national emergency, including one involving bioterrorism.

Under the rule, domestic and foreign manufacturers, packagers, sellers and importers would have to begin to register their devices and enter listing information into the Food and Drug Administration's Unified Registration and Listing System, unless the FDA has waived electronic submission.

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