Federal authorities in the Land of 10,000 Lakes sent a letter May 6 to Fridley, Minn.-based Medtronic requesting the information, according to a regulatory filing.
The TAA governs acquisitions of more than $193,000 by the U.S. government. Its "rule of origin" provision mandates that those products must be either made in the U.S. or from a "designated country" that’s part of a trade agreement with the U.S. But several countries that produce medical devices, including China, India, Malaysia, Taiwan and Thailand, are not designated countries under the act.
That means any U.S. government purchases from those nations are legal only if no U.S.-made or designated country-made alternatives are available.
Medtronic said it’s "fully cooperating with this inquiry," according to the filing.
“This inquiry was an informal letter from the U.S. Attorney’s Office to Medtronic,” a company representative told MassDevice.com in an email today.