Sen. Franken, Hamburg discuss device industry's concerns

Sen. Al Franken (D-MN) shared the medical device industry's concerns with regulators this week. He met with FDA Commissioner Margaret Hamburg as federal regulators are considering more than 70 changes to the 510(k) pre-market review process for low- and moderate-risk devices. Devicemakers say some changes are needed to simplify the process, but they're worried about the FDA's proposals to strengthen an expedited review process that they say has a strong safety record. "During our meeting on Thursday, the FDA Commissioner committed to working with me, as a member of the Senate committee that oversees the FDA, to address the concerns of Minnesota's medical device community," Franken said in a statement. Article | Story