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FDA Reviewing Information Requirements for Exports of Unapproved Medical Devices

Friday, April 05, 2013
By Shawn McCausland
Sandler, Travis & Rosenberg Trade Report

The Food and Drug Administration is soliciting comments through June 4 on the proposed extension of an information collection associated with foreign letters of approval for medical device exports. Section 801(e)(2) of the Federal Food, Drug and Cosmetic Act provides for the exportation of unapproved devices under certain circumstances if the exportation is not contrary to public health and safety and has the written authorization of the foreign country to which it is intended. An alternative to obtaining written authorization is to accept a notarized certification from a responsible company official in the U.S. that the device is not in conflict with the foreign country's laws. This certification must include a statement acknowledging that the official making the certification is subject to the provisions of 18 USC 1001, which makes it a criminal offense to knowingly and willingly make a false or fraudulent statement, or make or use a false document, in any manner within the jurisdiction of a U.S. department or agency.

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