You are here

P T. 2011;36(7): 395, 409
Prescription: Washington

Critics Assail FDA Medical Device Approval Process

Slow Review Time and Safety Are at Issue
Stephen Barlas

The FDA is attempting to respond to complaints about its procedures for approving medical devices. Those complaints come at the agency from different angles. Medical device companies say that if the FDA doesn’t speed up the process, foreign competitors will win the innovation race and hospitals in the U.S. will see patients go overseas for cutting-edge treatments that domestic hospitals can’t offer. The Government Accountability Office (GAO), on the other hand, has issued repeated reports criticizing the FDA’s approval process for various shortcomings that, hypothetically, could endanger patients who might receive a faulty implantable device, for example.

Stephen Ferguson, Chairman of the Board of Cook Group, Inc., a holding company for manufacturers of many diagnostic and interventional devices, says:

“There is a real concern that without improvement in the current regulatory system, the role of the United States as the leader in medical innovation will continue to decline and [will] result in the migration of patients seeking medical intervention abroad where innovation is thriving and available.”

Diana Zuckerman, PhD, President of the National Research Center for Women & Families in Washington, D.C., takes the opposing view. She says there are far too many recalls of medical devices. Between 2005 and 2009, there were 3,510 voluntary recalls, an average of just over 700 per year. The majority—nearly 83%—were classified by the FDA as Class II recalls. A Class II recall means that the use of, or exposure to, these devices could cause temporary or medically reversible adverse health consequences or that the probability of serious adverse health consequences is remote. Class I recalls are the most serious type, constituting only 4% of the total.

Dr. Zuckerman explains: “The bottom line is that even ‘moderate-risk’ recalled devices can sometimes result in death during surgery and certainly add billions to Medicare costs when they result in additional surgery and hospitalizations from the complications of defective devices.”

Because of perceived problems with the approval process, the GAO put the FDA’s review program on the federal government’s “high risk” list in 2009, where it has stayed, as the GAO has issued successive critical reports, mostly about the extent of recalls. The FDA responded by forming some internal review groups that made recommendations. In 2011, the agency announced that it was implementing these recommendations.

To respond to complaints from industry about the plodding pace of new device review, the FDA is promoting an “innovation pathway.” The agency held a public meeting on that topic in March. Its initial plan was to pick a couple of medical devices each year for expedited review; however, AdvaMed, the medical device trade group, argues that the FDA already has such a pathway—its Product Development Protocol review.

Janet Trunzo, Executive Vice President of Technical and Regulatory Affairs at AdvaMed, says:

The proposed Innovation Initiative contains many good ideas, such as early and consistent interaction and the focus on cooperative effort, which ultimately should be applied across the board to all devices to get safe and effective products developed and reviewed quickly. The FDA has a number of tools to achieve these objectives already available, and it should use them more broadly and effectively.

Minnie Baylor-Henry, worldwide Vice President of Regulatory Affairs for Johnson & Johnson Medical Devices and Diagnostics, notes that the agency has designated a brain-controlled robotic prosthetic arm as the first device to enter this innovation pathway. She agrees it is a radically different and revolutionary medical device and ought to be accorded an expedited review. She adds, however:

“Significantly redesigning a marketed device to allow it to be used safely and effectively at home can be an innovative breakthrough.”

She also says that the FDA should not focus exclusively on “technologically radical” developments.

The approval of new medical devices is not the only pressing issue facing the FDA—so is the classification of old devices. Since 1976, the FDA has been slowly classifying the 140 categories of devices that were on the market before that year, when Congress passed the Medical Device Amendments of 1976. That legislation, which amended the federal Food, Drug, and Cosmetic Act of 1938, required the FDA to categorize all medical devices as Class I, II, or III, with III representing the most potentially dangerous class, including, for example, implantable devices. Manufacturers of new Class III devices can submit a Pre-market Approval (PMA) application for an innovative device, in which case a clinical trial or similar study is required. Alternatively, a premarket notification states that the new device is similar to one that is already on the market. In this situation, detailed scientific information about safety and efficacy is not required—nor is it typically required for “new” Class I or II devices.

The 140 categories of devices are referred to as “pre-amendment” devices. Only 26 categories remain to be classified, but they include some widely used devices that, if identified as Class III, would have to be the subject of first-time clinical trials. Examples include automated external defibrillators, implantable hip joints, and electroconvulsive therapy devices that are used to treat depression. Manufacturers of these medical devices have hinted that they cannot afford clinical trials and would stop manufacturing the product if the FDA considered the devices to be Class III. However, patient advocacy groups counter that some of these devices are dangerous and should be banned or should at least be subject to restrictions imposed on hospitals where they are used.