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FDA Reviewing Information Collection on Medical Device Exports

Friday, April 22, 2016
Sandler, Travis & Rosenberg Trade Report

The Food and Drug Administration is accepting comments through June 21 on the proposed extension of an information collection concerning exports of medical devices.

Unapproved medical devices may be exported from the U.S. under certain circumstances if the exportation is not contrary to the public health and safety and has the approval of the foreign country to which it is intended for export. Requesters communicate (either directly or through a business associate in the foreign country) with a representative of the foreign government and written authorization must be obtained from the appropriate office within that government approving the importation of the medical device.

An alternative to obtaining written authorization is to accept a notarized certification from a responsible company official in the U.S. that the product 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 federal department or agency.

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