Preliminary recommendations outlining first steps in overhauling the way most medical devices are approved by federal regulators were released by the Food and Drug Administration late Tuesday.
The agency's medical device division has set its sights on revamping the 510(k) approval process -- which merely requires medical device makers to prove their product is similar to one already on the market before launching it commercially.
Because these devices are generally cleared without clinical studies to prove the products are safe and effective, critics have charged that potentially unsafe devices have made their way into the marketplace. But medical-technology companies and entrepreneurs -- including many in Minnesota -- argue the process works fairly well and simply needs tweaking.
Dr. Jeffrey Shuren, the freshman head of FDA's Center for Devices and Radiological Health, told reporters Tuesday that the proposed changes "show a smarter FDA -- an agency that recognizes both sides of our mission to protect and promote public health."
Six of the proposals
Among the recommendations released Tuesday:
•Creating a new class of devices that would require clinical evidence before gaining 510(k) approval. The designation would streamline the process for a "small subset" of devices by telling applicants up-front what will be required to gain marketing clearance, thus avoiding delays. Currently, only 8 to 10 percent of the devices approved under the 510(k) moniker require clinical studies, Shuren said.
•Streamlining the approval process for so-called de novo medical devices, those that aren't similar to a product currently on the market but are still relatively low-risk.
•Creating the Center Science Council, which that would oversee science-based decisions. Dr. William Maisel, now the director of the Medical Device Safety Institute at Beth Israel Deaconess Medical Center in Boston, will serve as its head beginning next week. Maisel, a well-known figure in med-tech circles, will also serve as the device division's chief scientist.
•"Enhancing" science-based training for the device division's staff, and establishing an outside group of experts to "better inform the review of cutting-edge technologies."
•Issuing "Notice to Industry" alerts to medical device makers to better communicate changes in preapproval expectations.
•Issuing guidelines on when a device on the market shouldn't be used as the basis for approval of a new device. That way, no further 510(k) approvals can be based on an unsafe product. Shuren noted that about 29 percent of 510(k) products cleared in 2009 were based on devices no longer on the market.
The FDA's recommendations come as the Institute of Medicine, a respected independent entity that provides advice to policymakers, engages in its own review of the 510(k) process. While the Institute's report isn't expected until next year, Shuren said the agency will move ahead.
He said some of the changes could be implemented "within a matter of weeks or months." The agency will seek public input for the next two months, as well.
"Some of these changes seem rather significant to me," said Ralph Hall, a professor at the University of Minnesota's law school. "I was surprised by how broad the suggestions are."
Hall recently spent several months studying recalls of medical devices that were approved through the 510(k) process. He said his research found that most safety problems were related to manufacturing or design mistakes -- normally not issues explored in human clinical trials.
Minneapolis attorney Mark DuVal, who specializes in FDA law, said, "Overall there's a lot of good, but there's still some questions and concerns. What I like about Dr. Shuren is he's trying to be predictable and transparent even though [ndustry] may not always agree with him."
On Wednesday, several Wall Street analysts weighed in on the proposed changes.
"The proposals are more benign than many had feared," wrote Leerink Swann analyst Rick Wise in a note to investors. " No radical change to the current process appears likely."
Morgan Stanley analyst David Lewis wrote, "On the bright side, FDA has clearly been listening to industry concerns over regulatory predictability."
Information on the proposed rules can be found here: www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHReports/ucm220272.htm
Janet Moore • 612-673-7752