Proposed Rule Calls for More Data on Imported Devices

The FDA is proposing that devicemakers importing products into the U.S. submit additional product identification information to allow the agency to better focus on products that pose greater risks and to speed up “May Proceed” determinations.

The FDA wants product identification data from the time of entry into a U.S. Customs and Border Protection (CBP) database, including:

• The country of production where the product was last manufactured;
• The complete FDA product code;
• The total value of an entry or the total value of the articles in each import line;
• The quantity of the product in each import line, including each layer of packaging;
• The registration and listing numbers of the domestic manufacturer (DDM), foreign manufacturer (DEV) and/or foreign exporter (DFE) for each medical device; and
• The device listing number, premarket number (including PMA, de novo, humanitarian device exemption, 510(k)).