Minnesota lawmakers caution FDA over proposed 510(k) changes

11/30/2010 | Star Tribune (Minneapolis-St. Paul, Minn.)

A bipartisan group of eight Minnesota lawmakers sent a letter to FDA Commissioner Dr. Margaret Hamburg saying the agency should present definite evidence that the proposed changes to the 510(k) process for clearing medical devices "are necessary to address a demonstrated public health concern." The medical device sector "is so important and vital to the state as a job provider and a source of innovation. We need to ensure that this industry remains a success story in Minnesota," said Rep. Erik Paulsen, R-Minn., one of the signatories of the letter.

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Star Tribune (Minneapolis-St. Paul, Minn.)

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