FDA Proposed Rule Requires 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).

The proposed rule also clarified that the same criteria be applied to medical device components (any raw material, substance, piece, part, software, firmware, labeling or assembly intended to be includes as part of the finished, packaged and labeled medical device); electrode lead wires and patient cables intended for use with a medical device; and convenience kits or parts of convenience kits imported or offered for import.

The goal is for this data to feed into the FDA’s Operational and Administrative System for Import Support, which is linked to CBP’s database and will authorize “May Proceed” determinations for low-risk imported drugs.

Comments are due within 60 days of publication in the Federal Register.

Read the proposed rule here: www.fdanews.com/06-30-16-ProposedRule.pdf. — Michael Cipriano