FDA seeks more industry opinion about device approval process

The Food and Drug Administration is looking for more input after receiving a recommendation last week that it scrap a controversial pathway for medical device approvals and design a new process.

FDA officials told device industry executives at a town hall meeting in St. Paul on Tuesday that they remain open to ideas to improve the 510(k) method of device reviews, which generally doesn't require clinical trials. The agency is gathering public comment, a process that should be complete by October.

"Let's have that discussion," said Dr. Jeffrey Shuren, head of the FDA's device division. "If there are any recommendations that make sense, we'll consider them."

Friday's recommendations from the prestigious Institute of Medicine (IOM) disappointed many in Minnesota's formidable medical technology community.

But Shuren, who appeared with his four top lieutenants, said Tuesday that the kind of drastic overhaul the IOM recommends is probably not necessary. "I don't think we should eliminate [the 510(k)] process in its entirety. It does have a role, it needs some fine-tuning."

In 2009, FDA asked the IOM, part of the National Academy of Sciences, to review the approval pathway after several safety recalls of medical devices in recent years.

In a town hall meeting at University Enterprise Laboratories in St. Paul, Shuren and his staff answered questions from the Twin Cities' med-tech elite for about an hour. The general theme: The agency's approval process needs to become more predictable and transparent, a common gripe levied by med-tech companies against the agency.

William Maisel, deputy center director for science and the device division's chief scientist, said it's "very important that you talk to us. We believe you are better off talking to us."

A quality program to monitor the advice FDA gives to applicants has been instituted to ensure a consistent, and therefore predictable, experience for companies when dealing with the FDA, he said.

About 60 people attended the town hall meeting Tuesday, which was planned long before the IOM controversy. It was the second town hall meeting the FDA has hosted in Minnesota, home to Medtronic Inc., the world's largest med-tech company, and hundreds of smaller brethren.

One attendee asked what role government should play in retaining highly coveted med-tech companies in the United States, especially after Boston Scientific's announcement last week that it was cutting some domestic jobs but adding 1,000 in China.

While repeating the mantra that FDA needs to be more "predictable, transparent and timely" in its approval process, Shuren said corporate decisions are "due to a lot of factors. Sometimes it's FDA, but not always. Sometimes companies just need people in-country."