FOREIGN FIRMS WILL HAVE DIRECT RESPONSIBILITY FOR MDR WITH IMPLEMENTATION OF RULE ON JULY 31; STAY WILL ELIMINATE U.S. AGENT, CEO CERTIFICATION LANGUAGE
This article was originally published in The Gray Sheet
Foreign device manufacturers who sell products in the U.S. will be required to report adverse events directly to FDA as of July 31, when FDA's medical device reporting rule goes into effect, agency staffers say.
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