Fast FDA Medical Device Approval Flawed?

The adage “more haste, less speed” could perhaps apply to the abbreviated approval pathway the U.S. Food and Drug Administration (FDA) has in place for medical devices. Known as the 510(k) process, it is popular with the medical device industry because it can save time and money in regulatory reviews. But as reported in the Los Angeles Times and The Wall Street Journal, a recent study shows that a majority of devices recalled in the mid-to-late 2000s was approved by this process, raising concerns that it’s too lax.

Medical devices are reviewed by the FDA in one of two ways: a premarket approval (PMA), which requires clinical testing and inspections, and the 510(k) process, which requires the device be similar to a device already marketed. The second pathway is meant for devices that the FDA considers to be low or moderate in risk.

But questions were raised about the 510 (k) process in a study published in the Archives of  Internal Medicine by Dr. Diana Zuckerman and Paul Brown at the National Research Center for Women & Families, a health-research group in Washington, D.C., and cardiologist Dr. Steven Nissen at the Cleveland Clinic in Ohio. The investigators analyzed the FDA’s high-risk List of Device Recalls from 2005 through 2009. They then figured out, using data from the FDA, whether the recalled devices were approved by the more rigorous PMA process, the 510(k) process, or in some cases, were exempt from FDA review.

They found that of 113 medical devices recalled in the four-year time period, 80 were sent to market through the 510(k) program. About a third of the recalled devices were cardiovascular products, including several brands of external defibrillators. (Quite fitting that the study appeared on Valentine’s Day.)

The authors concluded, “These findings suggest that reform of the regulatory process is needed to ensure the safety of medical devices.” The authors suggest that the FDA should either decrease the number of medical devices they approve under the 510(k) procedure or come up with a new pathway that sits between the existing two procedures in terms of stringency and rigor.

Andrew Zajac, a reporter with the Los Angeles Times‘ Washington Bureau, writes in his article on the topic, “The study is the latest chapter in a bitter debate between device makers and public health advocates. In August, the FDA released a draft of new rules that added stricter requirements to the shorter process.”

But as Alicia Mundy, a seasoned pharmaceutical industry reporter, and Jon Kamp, Deputy Bureau Chief for Dow Jones Newswires, explain in their Wall Street Journal article, the FDA “put off some of its toughest proposals for further study under pressure from device makers.”

Source: “Device Review Process Faulted,” Wall Street Journal, 02/15/2011
Source: “Most Recalled Medical Devices Received Speedy FDA Review,” Los Angeles Times, 02/15/2011
Source: “Medical Device Recalls and the FDA Approval Process, Archives of Internal Medicine,” 02/14/2011
Image by David Bruce Jr./Frederick Md Publicity, used under its Creative Commons license