Medtronic pleased with FDA's plans to streamline approval processby Rupa Shenoy, Minnesota Public Radio
St. Paul, Minn. — Minnesota medical-device maker Medtronic says it's pleased the Food and Drug Administration decided not to follow the recommendations of an internal task force to tighten rules for approving medical devices.
The FDA announced Wednesday that it will take 25 steps this year to streamline the approval process for medical devices that fall under the agency's 510k program.
Those steps omit the most controversial of 55 proposals made in August by an internal agency task force. The med-tech industry feared some provisions would slow approval of new products.
"What we're most heartened by is that the FDA has taken into consideration viewpoints from a number of different stakeholders in looking at how best to improve the process," said Medtronic spokesman Brian Henry. "We look forward to working with the FDA to find ways again to bring more consistency to the process, so that we know what we need to bring to the table when we go to approvals for our products."
Henry said the approval process for new devices such as those used to do spinal procedures or ear, nose and throat checks will be affected by the FDA changes.