By Kirell Lakhman

The FDA may be shoulder-deep in streamlining its 510(k)-review process — and may issue a guidance about it as early as this spring — but the regulatory machinery with which it has been tinkering for the past month may be in rougher shape than anyone knew, according to a new study.

In fact, despite FDA's recent 25-point plan to improve the process and its call for comments, a congressional committee held a hearing on the topic three days after the study was published, prompted by the agency's meek track record of reviewing medical devices, including clinical tests.

The paper, which appears in the Feb. 14 Archives of Internal Medicine, found that over a four-year period 510(k)-cleared medical devices represented the vast majority of all approved devices to have been recalled due to "serious life-threatening" events

'Critical Flaws'

These findings are not only newsworthy on their own. They could be particularly noteworthy for clinical labs that will soon be forced to work with CDRH, which is responsible for 510(k) reviews, as FDA continues to consider dropping its policy of enforcement discretion and reclassifying some LDTs as IVDs.

First labs and test makers get a glimpse of how expensive the regulatory requirements they're facing will be. Now some say they're seeing how poorly that money has been spent.

According to the AIM study, between 2005 and 2009 FDA recalled 113 devices, originally cleared through various regulatory routes, after it concluded they "could cause serious health problems or death." Eighty of them were given 510(k) clearance.

Particularly noteworthy for clinical labs and test makers is the paper's finding that 10 of the recalled devices, or 9 percent of the total, were "chemical-analysis devices such as glucose meters and other diagnostic-testing equipment."

"These findings suggest that reform of the regulatory process is needed to ensure the safety of medical devices," the study concluded.

'Serious Harm'

According to the paper, FDA recalled the devices, including the tests, "because they could seriously harm patients or result in death," the paper found. And "most medical devices recalled for life-threatening or very serious hazards" were cleared via the 510(k) route. [Emphasis added.]

According to the paper, 21 devices, or 19 percent of the 113 recalls, were cleared through the highly stringent PMA process; 80, or 71 percent, were cleared through the less-critical 510(k) process; and eight devices, or 7 percent of the total, were exempt from any kind FDA regulation.

Seventy-one percent is a large majority, thus it is critical for the clinical lab community — labs and test makers alike — to consider strongly the study's findings, especially since FDA prepares to flip the switch on its controversial plan to require some LDTs to undergo 510(k) review (see here, here, here, here, and here).

And even though none of the recalled tests that appeared in the study were LDTs, and, according to an FDA spokesperson, "the devices that fail tend not to be IVDs," the paper's conclusions would "probably [have a] very minimal" effect on the agency's plan to reclassify LDTs as IVDs (a plan that is "still underway," she added).

Fair enough, but that's not the point. The AIM study criticized the 510(k)-approval process for being in desperate need of "reform," which many labs will soon witness as enforcement discretion breathes its last breath.

"Our findings reveal critical flaws in the current FDA device-review system and its implementation that will require either congressional action or major changes in regulatory policy," the study reported.

As it happened, three days after the paper appeared a congressional committee held a hearing on the topic, though with a focus on job creation. (Transcripts of the hearing, held by the House Energy and Commerce Committee's Subcommittee on Health, can be found here.)

At the hearing, entitled “Impact of Medical Device Regulation on Jobs and Patients,” CDRH Director Jeffrey Shuren testified and largely played defense. He said FDA must give device manufacturers "clearer guidance" about approval standards — especially in light of the impending LDT transition — "to keep the US system competitive."

According to the Wall Street Journal, Shuren didn't mention devices recalled for their "life-threatening or very serious hazards" or offer any specifics about fixing the process.

However, like a burglar blaming the homeowner for not keeping all his valuables in one place, Shuren pinned some of the blame on device makers by saying "industry isn't pulling its fair share," according to the Journal (A transcript of his written testimony can be found here.)

Shuren's tin ear matches FDA's rusty regulatory machinery.

Coincidentally, one witness during the hearing was Steven Nissen, a Cleveland Clinic cardiologist and co-author of the AIM study. At the event he said "the FDA has become more risk-averse," while another griped that it sometimes makes "impossible" demands for "extraordinary" data. (A transcript of Nissen's written remarks can be found here.)

Settling into the political middle ground was Rep. Mike Burgess of Texas, a Republican and a physician, who told the Journal following the hearing that the FDA and device manufacturers "have a big failure to communicate."

Shuren "keeps saying [device manufacturers] don't come to the FDA to talk about what they are doing [and claiming and] … the FDA is changing the game all the time," Rep. Burgess added.

'Perspective'

Asked for comment, an FDA spokesperson said via e-mail that while "even one recall is too many, … it’s important to keep the 80 recalls [that had been cleared through the 510(k) route] in perspective."

She said more than 19,000 devices were given 510(k) clearances in the years tracked by the study, and the recalled devices "represent a small number of the devices cleared via this program and don’t reflect the thousands of people who have benefited from these devices."

Indeed, since "more than 90 percent of devices (that require premarket review) are cleared via the 510(k) pathway, it’s not surprising that the majority of recalled devices are 510(k)," she added.

Responding to the study author's call to "reform the regulatory process," the spokesperson noted that "CDRH completed a thorough review of the 510(k) program" and mentioned its 25-step plan "designed to strengthen the program."

Moreover, she said the findings in the AIM paper "are not new. Similar analyses have been publicly presented that show an annual recall rate (including all recalls, not just 'high-risk') for 510(k) devices of 1-1.5 percent per year," the spokesperson said.

Pointing to the specific findings of the study, she said 13 of the 80 “high-risk” 510(k) recalls involved Class III devices "that the agency is already evaluating to either down-classify to Class II" or upgrade to PMAs.

Meantime, 10 of those 13 involved external defibrillators, "a device class for which the FDA announced its external defibrillator initiative in 2010, held a public workshop in December 2010 and [held] a panel meeting to consider reclassification in January 2011."

"The FDA has committed to evaluating all remaining Class III 510(k) devices by December 2012 for either down-classification to Class II or to require PMAs and has a page on the CDRH website providing status updates for each device type," the spokesperson said.

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