In a move akin to Martin Luther nailing his theses to a wall, the Institute of Medicine (IOM) released its long awaited and controversial recommendations for the revision of the 510(k) product clearance process.

Heather Thompson

July 29, 2011

3 Min Read
Epic Fail: IOM Disappoints in 510(k)s by Not Doing Its Job

I say long awaited because the report comes more than six months after FDA released its plans in January to implement 47 of the 55 recommendations that its 510(k) working group published in August 2010. And I say controversial because the IOM has come under fire for not including any industry members or patients on its working panel. As such, the IOM panel appeared to have stacked the deck against industry interests, which could negatively affect the medical device market.

But the IOM effectively took the wind out of the conversation, because it did not even attempt to make recommendations to fix 510(k). Instead it told FDA not to waste its resources. “The IOM finds that the current 510(k) process is flawed based on its legislative foundation,” says the report. “Rather than continuing to modify the 35-year-old 510(k) process, the IOM concludes that the FDA’s finite resources would be better invested in developing an integrated premarket and postmarket regulatory framework that provides a reasonable assurance of safety and effectiveness throughout the device life cycle.”

In a public webcast, IOM panel chairman David Challoner said the panel was unanimous and that the IOM hoped to spur a conversation, not make suggestions on how to replace 510(k). I’d say making recommendations was exactly why the IOM was tasked with the 510(k) process int he first place. That it simply refused to do so is also a waste of FDA's resources.

The debate thus far over IOM’s report has been loud. Most industry experts were prepared to immediately dismiss any recommendations to the 510(k) as overregulation. But the pronouncement from the IOM took even regulators by surprise. FDA scrambled to assure industry that it wasn’t prepared to give up on 510(k). “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 director Jeffrey Shuren said in a news release.

Shuren is not alone in his dissatisfaction. “The report is extremely disappointing, given the time and effort that has been dedicated to this process,” notes John Smith, a partner in law firm Hogan Lovells’ life sciences practice. “The institute’s primary conclusion that the 510(k) process should be abandoned completely ignores the considerable debate that led to its creation and the successful application of the 510(k) paradigm over 35 years.” 

Likewise, AdvaMed spokesperson Stephen J. Ubl blasted the report. “The report’s conclusions do not deserve serious consideration from the Congress or the administration,” Ubl railed in a press release. “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.”

Beyond the recommendation to scrap 510(k), the IOM did not adequately address how to do so or venture what might replace the system. “The institute fails to offer concrete recommendations as to potential alternatives, likely reflecting how difficult it will be to improve on the existing 510(k) paradigm,” says Smith.

The IOM made the following recommendations about device regulations in general:

  • FDA should develop and implement a strategy to collect, analyze, and act on postmarket performance information.

  • FDA should review its postmarket regulatory authorities for medical devices to identify existing limitations on their use and to determine how the limitations can be addressed.

  • FDA should investigate the viability of a modified de novo process as a mechanism for evaluating the safety and effectiveness of Class II devices.

  • FDA should commission an assessment to determine the effect of its regulatory process for Class II devices on facilitating or inhibiting innovation in the medical device industry.

  • FDA should develop procedures that ensure the safety and effectiveness of software used in devices, software used as devices, and software used as a tool in producing devices.

The fact remains, however, that the IOM did not do what it was asked to do—comment on seven specific questions highlighted by the 510(k) working panel. Can FDA get its money back?

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