Is FDA Speeding Up Device Approvals? Yes and No.Is FDA Speeding Up Device Approvals? Yes and No.

Are we there yet?

That familiar plea from the back seat of the family car might well be coming from medtech manufacturers seeking device approvals from the FDA.

According to a report titled Taking the Pulse of Medical Device Regulation and Innovation by the California Healthcare Initiative (CHI), the answer to that question is "not quite," particularly when it comes to 510(k) reviews.

PMA approval times in 2011 and 2012 were the best since pre-device user fees were imposed in 2002, the report says. Last year showed more improvement, but the report says it's too early to tell, given the number of products awaiting a decision.

The agency's approval process continues to lag three to five years behind that in Europe, despite the increased user fee, which was intended to help FDA to improve its processes, a CHI spokesperson said.

The nonprofit organization, which produced a similar document in 2011, worked closely on the study with Jeff Shuren, MD, director of the FDA's Center for Devices and Radiological Health. It examined issues that directly affect medical device approvals, such as decision and process efficiency and outcomes, providing context on legislative regulations governing FDA medtech product review processes and procedures.

Clearance times for 510(k)s have "lengthened dramatically,with review times in 2010 being 60 percent longer than in 2000," a CHI statement said. "Even with some improvements over the past couple years, 510(k) review times continue to remain far higher, and processes are still viewed as less predictable, than during the pre-device user fee era," which ended in 2002.

Conversely, the FDA's 510(k) backlog has begun to improve, especially for those applications pending for more than 90 days.

"However, by nearly any measure, there is still much work to be done before the 510(k) process is considered back on track," the statement says.

The study acknowledged that the agency receives far more applications for 510(k) approvals (about 3000 per year) compared with 30 PMA devices.  CHI's review of FDA division branch performance struck a hopeful note.

Review divisions have varied markedly in meeting their PMA and 510(k) performance goals, the study says, but points to a trend in narrowing those gaps.

"The evidence is overwhelming that leaders at the Agency and, in particular, its Center for Devices and Radiological Health (CDRH) have worked to get processes, internally and with industry, back on track," it says.

Although the organization only studied the FDA's performance, its president and CEO, Todd Gillenwater, acknowledged that the agency is not the only obstacle in the U.S. medtech approval process. It cites "the overarching regulatory environment," plus intellectual property and patent law challenges, particularly with Medicare and the private payer system.

Nancy Crotti is a contributor to Qmed and MPMN.

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