Dump the 510(k) process. At the end of the day, that was the Institute of Medicine's (IOM) advice to the FDA in its much-anticipated report Friday.
The nonprofit group, tasked by the FDA to generate the report, recommended a new framework be established for reviewing medical products. It proposes, for example, that the FDA make device companies prove the safety and effectiveness of certain devices on their own merits, Bloomberg reports. Of course, the current 510(k) process calls for the agency to clear qualified devices that manufacturers have demonstrated are "substantially equivalent" to another product on the market.
David Challoner, chair of the committee that reviewed the process, had some tough words for the FDA. "It's not clear that the 510(k) process is serving the needs of either industry or patients, and simply modifying it again will not help," he said in a statement. "The 510(k) process cannot achieve its stated goals--to promote innovation and make safe, effective devices available to patients in a timely manner--because they are fundamentally at odds with the statutes that govern how FDA must implement the process."
The report got the attention of several high-profile 510(k) defenders, including the FDA, which has been taking steps to overhaul how it reviews devices. "FDA believes that the 510(k) process should not be eliminated but we are open to additional proposals and approaches for continued improvement of our device review programs," CDRH head Jeffrey Shuren said. The agency now wants public comment on the report to commence and plans to hold a public meeting to discuss the issue in the coming weeks.
AdvaMed, a medical devices industry group, blasted the IOM's report. "It proposes abandoning efforts to address the serious problems with the administration of the current program by replacing it at some unknown date with an untried, unproven and unspecified new legal structure," said the group's President and CEO Stephen Ubl. "This would be a disservice to patients and the public health."
None of this is to say that manufacturers and industry watchers believe the FDA's current process is perfect. There's been wide acknowledgement that the agency has been inconsistent in its regulation of devices, dragged its feet on considering devicemakers' applications for market clearance, and needs to reform its ways.
"It is not technology, science, ingenuity or the economy that is standing in the way of success in developing new medical technologies. In my opinion, it is today the FDA," medical devices inventor Robert Fischell told a subcommittee of the House Energy and Commerce Committee last month, as quoted by the LA Times.
"The key question now is what does FDA does with the report," says John Manthei, global co-chair of Latham & Watkins' Healthcare and Life Sciences Practice Group. "Interestingly, IOM did not weigh in on the specific recommendations from the FDA." He adds that Congress should be looking at the recommendations carefully--especially those who have been criticical of the FDA's performance.
Free eBook: The FDA's 510(k) Initiative