FDA Center for Devices & Radiological Health director Dr. Jeffrey Shuren asked med-tech officials at a town hall meeting in St. Paul, Minn. to pitch in with ways to help improve the agency’s medical device review fast-track, reassuring industry that the 510(k) process isn’t going anywhere.
"I don’t think we should eliminate [the 510(k)] process in its entirety. It does have a role, it needs some fine-tuning," he said.
Shuren and four of his lieutenants fielded questions for about an hour on Tuesday, handling a battery of the usual concerns regarding consistency and transparency in the medical device review process, the Star Tribune reported.
The dramatic overhaul that the IOM recommended was dismissed as unnecessary. The FDA opened the report for public comment this week.
"Let’s have that discussion," Shuren said. "If there are any recommendations that make sense, we’ll consider them."
During the two-day visit to the North Star State, which is home to med-tech goliath Medtronic Inc. (NYSE:MDT), Shuren also announced that medical device reviewers at the FDA would start training and certification programs this year and that the agency would collaborate with trade group LifeScience Alley to develop regulatory science standards.
