Effectiveness of 510(k) Debated

NEWS TRENDS

The heat that FDA is feeling over its medical device approval process increased in late September after the agency admitted that four congressmen and its own former commissioner intervened to get a device approved that often failed. The news came fresh off the heels of the agency's announcement that it had commissioned the Institute of Medicine (IOM) to study the 510(k) premarket notification system.

Donna-Bea Tillman, who leads the Office of Device Evaluation at CDRH, circulated an internal memo shortly after the announcement asking for “a better lay of the land” in terms of device approvals. Specifically, she wants branch chiefs to let her know when reviewers are asked to clear a new indication or use that “you have never cleared for that device type.” Several FDA staffers say that such individual applications don't usually reach that far up the food chain at the agency.
According to the memo, FDA has already set up a working group to address 510(k) issues. Tillman also said in the memo that increased scrutiny is “just the first of what I am sure will be many things” done to improve the 510(k) process.
FDA has also issued a report saying that it will reevaluate the approval of Menaflex, a collagen scaffold for injured knees manufactured by ReGen Biologics Inc. (Hackensack, NJ), because the device was mistakenly approved. According to the New York Times, the agency's internal documents show that the device often failed, which forced patients to get another operation. However, after receiving “extreme” and “unusual” pressure from four legislators, as well as influence from former commissioner Andrew von Eschenbach, agency managers approved it.
The legislators, four Democrats from New Jersey, were Representatives Frank Pallone Jr. and Steven Rothman and Senators Robert Menendez and Frank R. Lautenberg. They all received significant campaign contributions from ReGen before making their inquiries but denied that the money influenced them. Similarly, von Eschenbach denies any wrongdoing, and ReGen continues to support its device.
“ReGen stands behind Menaflex and believes that the scientific evidence for its collagen scaffold is solid,” said president and CEO Gerald Bisbee Jr., PhD, in a statement.
The review process has come under intense observation over the past year. Safety watchdogs have contended that high-risk devices seemed to slip through the 510(k) instead of the more rigorous premarket approval (PMA) process.
In March, then-FDA commissioner von Eshcenbach said that use of the 510(k) was out of control. At a House hearing in June, the Government Accountability Office said it saw “serious shortcomings” in FDA's ability to regulate medical devices. It found hip replacements, heart implants, and more than 20 other device types that were granted approval without close examination. In August, CDRH director Daniel Schultz stepped down amid a plethora of controversies, including allegations of management interference in approval decisions.
FDA, recognizing that it needed help in escaping the morass of dubious approvals, called on the nonprofit IOM to review the 510(k) process. But there continues to be debate about whether the process itself is broken or whether it has simply been run by people who didn't allow science to be the sole factor in device approvals. AdvaMed continues to support the 510(k) process.
“AdvaMed strongly supports FDA's current risk-based approach to medical device regulation. The 510(k) process gives robust protections to American patients and promotes medical innovation by providing FDA the flexibility it needs to ensure the safety and effectiveness of low- and moderate-risk medical devices,” said Janet Trunzo, AdvaMed's vice president of technology and regulatory affairs, in a statement.
IOM recommendations for FDA's device division are still years away; acting CDRH director Jeffrey Shuren says the IOM review won't be complete until 2011.
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