Al FrankenAl FrankenTax reform an important part of pro-consumer energy policy We need congressional debate on Yemen The case against Gorsuch: It’s all about precedent MORE (D-Minn.) shared the medical device industry's concerns with regulators this week. The senator's meeting with Food and Drug Administration Commissioner Margaret Hamburg comes as federal regulators are considering more than 70 changes to the 510(k) pre-market review process for low- and moderate-risk devices.
Device makers 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. Minnesota has more than 400 device companies employing more than 30,000 people.
"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. "I pressed her to take these concerns seriously as the FDA modifies the 510(k) program and to seek public input at every step in the process. We must continue to ensure patient safety, but not at the expense of innovation and the opportunities to get new products to the market that can improve patients’ lives."
The meeting comes after Franken held a summit in Minnesota last month with medical device manufacturers to hear their concerns about the regulatory process.