US Medical Device Industry Pushes Back Against Proposed FDA Changes

The $200 billion U.S. medical-device industry voiced concern Tuesday about "potentially disruptive" proposed changes to a widely used device-approval process at the Food and Drug Administration, which the industry thinks should instead pursue limited changes.

Comments from the Advanced Medical Technology Association trade group come as the FDA closes a window for input on wide-ranging proposals to shore up the so-called 510(k) device-approval process. This system is relied upon heavily by big device companies, especially makers of orthopedic implants like Zimmer Holdings Inc. (ZMH) and Johnson & Johnson (JNJ).

But the FDA is reviewing its 510(k) rules amid criticism that they have been too lax and inconsistently applied. Non-profit advocacy group Public Citizen, for example, said the process "has failed to keep dangerous and ineffective medical devices from the market."

AdvaMed has pushed against a major overhaul, saying the process works well already and needs only modest updating. AdvaMed last month highlighted a report, conducted by an outside group with AdvaMed financial backing, showing only a tiny fraction of devices approved through the 510(k) process since 1998 were involved in serious recalls. The device group wants to see some steps like more training for FDA reviewers, but not other moves such as beefed up FDA authority to rescind device approvals.

"Wholesale changes to a program that has such a strong record of protecting American patients while facilitating innovation and timely patient access to improved medical devices and diagnostics are not needed," said Stephen J. Ubl, AdvaMed's president and chief executive, in a release Tuesday.

On Monday, the FDA's deadline for comments on proposed modifications, AdvaMed filed a 107-page report outlining its positions. The FDA has said it could make some 510(k) changes this year, after taking public comments into account. Though few filings are posted on the agency's website thus far, spokeswoman Erica Jefferson said the FDA has received more than 60 comments.

The 510(k) process can be a cheaper and faster option in comparison with another FDA pathway that typically has higher requirements for medical evidence, and focuses on high-risk products. To qualify for a 510(k) review, companies must show there is an already approved device similar to the new product.

How this requirement is interpreted has generated controversy, including in the case of the FDA's approval for a ReGen Biologics Inc. (RGBO) knee device in 2008. The FDA kicked off its 510(k) review last year after issuing a self-critical report that said top regulators bowed to outside political pressure when approving that device.

Articles in The Wall Street Journal had pointed to the political pressure and other irregularities in the ReGen case. ReGen said its device was safe and effective and defended its activities before the FDA.

Among the FDA's proposals, AdvaMed doesn't like the idea of creating a subset of "Class II" devices--generally products with moderate risk to patients--which would require clinical or manufacturing data. AdvaMed has supported identifying a "small, focused subset" of these devices, but is concerned the FDA is targeting a much broader range of products.

Public Citizen, in contrast, voiced strong support for dividing Class II devices and said the FDA should require clinical data for all devices in this new Class IIb category. The FDA has said drug-infusion pumps--ubiquitous hospital products with a history of performance issues at multiple manufacturers, including Baxter International Inc. (BAX)--are one example that falls into this new category.

AdvaMed voiced concern that the FDA's proposals to resolve confusion about certain key 510(k) terms could instead add confusion and delay product clearances. AdvaMed also took issue with the FDA's proposal to bolster its authority to consider unapproved, or "off-label," device uses the actual intended uses for products.

How doctors use approved products is up to them, but companies can't market devices for unapproved purposes. This FDA proposal could stop companies from dodging a review process for off-label markets even if they are really banking on doing big business in those markets. But the FDA's proposal "could prevent needed technologies from reaching patients," AdvaMed argued, while saying the FDA already has authority to deal with inappropriate device promotion.

Further 510(k) changes could come next year after an FDA-requested review by the nonprofit Institute of Medicine wraps up.

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

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