(World Trade Interactive)
The Food and Drug Administration is proposing to amend its regulations governing medical device establishment registration and medical device listing to reflect statutory changes in the Food and Drug Administration Amendments Act of 2007. The FDAAA requires domestic and foreign medical device establishments to submit their registration and device listing information by electronic means rather than on paper forms. Comments on this proposed rule should be submitted no later than June 24.
According to FDA, this rule proposes the following changes to the current registration and listing regulations.
Electronic Registration and Listing
Current regulations require owners and operators of device establishments to submit their registration and listing information to FDA using paper forms (forms FDA 2891, FDA 2891a and FDA 2892). This proposal would require such information to be provided electronically unless FDA grants a request for a waiver. Device establishment owners and operators have been using the FDA Unified Registration and Listing System to meet this requirement since the system became operational Oct. 1, 2007. FDA grants waivers only to those owners or operators for whom electronic registration and listing is not reasonable.
FDA believes that FURLS will ultimately make the process of submitting registration and listing information more efficient for industry and will provide faster access to this information for both FDA and industry. This, in turn, will help FDA accomplish a number of important statutory and regulatory objectives, including identifying establishments producing marketed medical devices, facilitating the recall of devices marketed by owners or operators of device establishments, administering FDA’s post-marketing surveillance programs for devices, identifying devices marketed in violation of the law, identifying and controlling devices imported or offered for import from foreign establishments, and scheduling and planning inspections of registered establishments.
This proposal would reflect the Bioterrorism Act requirement that foreign establishments whose devices are imported or offered for import into the U.S. must identify all importers known to them and the name of each person who imports or offers to import their device into the U.S. The rule would also eliminate the registration and listing exemption for foreign establishments whose devices enter a foreign-trade zone and are re-exported from the FTZ without entering U.S. commerce.
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