The Institute of Medicine’s report on the FDA’s 510(k) clearance process for medical devices falls so far out of the scope of the questions it was meant to answer that it’s essentially meaningless, med-tech industry reps told the agency during negotiations over re-authorizing the Medical Device User Fee & Modernization Act.
Representatives from Boston Scientific (NYSE:BSX), Quest Diagnostics (NYSE:DGX), Laboratory Corp. (NYSE:LH), the Advanced Medical Technology Assn., the Medical Device Manufacturers Assn., the Medical Imaging Technology Alliance met with the federal watchdog agency August 9 to negotiate the structure of the new MDUFMA. Minutes from the meeting reveal that the med-tech industry takes a dim view of the IOM report, which was nearly 2 years and $1.3 million in the making.
"Industry indicated that the IOM’s recommendations were so far outside the scope that the report does not provide meaningful answers to the questions FDA asked," according to the minutes. "Industry also expressed concern with the IOM’s statement that the 510(k) program is not designed to address safety and effectiveness, and encouraged FDA to rebut this contention."
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The FDA tapped the medical institute for a soup-to-nuts review of the program in late 2009. The report, published in late July, astonished the agency and the industry alike with its recommendation that the 510(k) program be scrapped. Even before the report dropped, the FDA took pains to assert its independence, going so far as to proclaim that it’s "not bound" by the report’s findings.
The FDA “will consider them and make its own decisions,” according to minutes of another meeting June 17 between the device industry and agency officials.
"FDA reiterated that the Agency does not believe the 510(k) program should be eliminated; it works well for most devices. FDA acknowledged that some increasingly complex devices stretch the boundaries of the program, and FDA is looking for ways to better address them," according to the minutes of the August 9 meeting.
As for the industry’s concern over the IOM’s contention that the workhorse 510(k) program isn’t delivering on its aim of ensuring safety and effectiveness, "FDA noted that the IOM acknowledged that there is not a public health crisis relating to the 510(k) program," according to the August 9 minutes.
"FDA further indicated that the agency plans to address this issue in its formal response in October," according to the August 9 minutes. "FDA plans to review the public input and then announce by the end of October what, if any, recommendations the agency would adopt. FDA is already in the process of implementing the last recommendation (calling for PMA applications for or reclassifying Class III devices that remain eligible for 510(k) clearance), with a targeted completion by the end of 2012."