The Institute of Medicine’s long-awaited report on the FDA’s 510(k) medical device review program, which dropped this morning, recommends that the federal watchdog agency ditch the program entirely and replace it with an “integrated pre-market and post-market regulatory framework.”
The 22-month, independent IOM review, commissioned in 2009 by the FDA’s Center for Devices & Radiological Health, is not binding on the agency but is sure to cause a stir in med-tech circles. The agency adopted a slate of less-controversial changes to the program, by which most medical devices are cleared for the U.S. market, but punted on implementing some of its more controversial proposals until publication of the IOM review.
With that out of the way, all eyes are on the agency as it digests the IOM’s recommendations and charts its course for what could be further, radical changes to the program.
“It’s not clear that the 510(k) process is serving the needs of either the industry or patients, and simply modifying it again will not help,” said David Challoner, who chaired the committee that wrote the report. “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 reaction from the medical device industry was swift and condemnatory.
“The report’s conclusions do not deserve serious consideration from the Congress or the Administration,” said Stephen Ubl, president and CEO of the Advanced Medical Technology Assn., in prepared remarks. “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. This would be a disservice to patients and the public health.
“Numerous academic studies have shown that the 510(k) process is overwhelmingly safe. The IOM committee itself acknowledges that there is no evidence that the 510(k) process is failing to assure safety and effectiveness. Yet the report recommends entirely scrapping this proven process with a vague new plan that contains no useful guidance. It even goes so far as to say that further investment in 510(k) process improvements would not be ‘a wise use of FDA resources.'”