FDA Device-Process Review Adds To Pressure On Device Makers


The Food and Drug Administration‘s review of a fast-track approval pathway for medical devices opens the door for changes to a process manufacturers commonly use to get products to market cheaply and quickly.

Among devices companies, more stringent “510(k)” rules would likely affect replacement joint makers such as Zimmer Holdings Inc. (ZMH) and Stryker Corp. (SYK) more than heart-device companies, because key orthopedics products are cleared this way.

The regulatory pathway, which has drawn criticism for leniency, is intended for devices deemed similar to already approved products. While potential changes remain unclear, the FDA does appear serious about examining the matter, which adds to the pressures facing device makers.

The agency “certainly is in a phase where scrutiny has increased again,” said Jan Pietzsch, an expert on medical-device regulation at Stanford University.

The FDA’s recent review of its controversial approval for a knee device dredged up issues with the 510(k) process itself and led the agency to ask an influential outside group – the Institute of Medicine – to investigate the matter. An FDA working group also is looking at ways to strengthen the 510(k) program.

Leerink Swann analyst Rick Wise said he’s “very much concerned” about tighter regulations that could slow the pace of innovation. Device companies commonly rely on upgraded products cleared through 510(k) that can fetch higher prices from hospitals.

The latest 510(k) questions come as the industry battles a proposal in the Senate for a $4 billion-per-year fee, weak hospital spending and the possibility of health reform dragging product prices lower.

The Advanced Medical Technology Association trade group, or AdvaMed, has welcomed the IOM’s 510(k) review, which should lead to a report in 2011. David Nexon, senior executive vice president at AdvaMed, said he could see smaller-scale internal FDA changes to ensure transparency and consistency, but not fundamental changes to the process.

Officially known as the premarket notification process, 510(k) represents the most common way medical devices are approved in the U.S. The more stringent process, known as premarket approval, or PMA, typically requires clinical evidence to show new devices are safe and effective.

The 510(k) pathway is quicker and cheaper because it usually doesn’t require clinical studies and because the FDA does faster reviews. The key 510(K) requirement is to prove new products are “substantially equivalent” to something already approved. This accommodates the fact that devices are frequently tweaked and improved over the years, and therefore may not need the same vetting as something designed from scratch.

But critics feel the FDA has been too lax in interpreting the rules. “Everybody agrees the agency has helped itself to a lot of discretion,” said Peter Lurie, deputy director of the Health Research Group at consumer advocacy organization Public Citizen.

Lurie wants products with different technology than comparison devices to take the tougher PMA route, and he wants to see more clinical trials for 510(k) devices. The Government Accountability Office has said the FDA should make sure more complex devices use the tougher regulatory pathway, which isn’t always the case, or get reclassified. The agency is reviewing that issue.

AdvaMed’s Nexon said any process can be improved, but that “our companies do not feel that they’re getting a free ride or that things are going through the 510(k) process that should be PMAs.”

The FDA seems to recognize room for improvement, as evidenced by its assessment of problems in the 510(k) review of a ReGen Biologics Inc. (RGBO) knee device. The agency’s report on the matter last month also included a broader look at the regulatory process.

The report noted a “central internal dispute” about 510(k) review standards, for example. The question now is how that dispute will be resolved, and whether device makers will find a less accommodating FDA as a result.

-By Jon Kamp, Dow Jones Newswires; 617-654-6728; jon.kamp@dowjones.com

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