Foreign establishment requirements
This article was originally published in The Gray Sheet
Firms in countries with which the U.S. has free trade agreements should not be required to identify U.S. agents, the Medical Device Manufacturers Association asserts in Oct. 7 comments on FDA's May 14 proposed rule to implement foreign establishment provisions in Sec. 417 of FDAMA. MDMA acknowledges the need for foreign companies to register and list their products with FDA, but maintains that these requirements "should be sufficient to protect patient safety and the public health." The comments follow earlier MDMA complaints that FDA's April 2 proposed rule concerning device companies exporting products was too stringent in its notification and recordkeeping requirements (1"The Gray Sheet" May 31, p. 9)
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