Most Recalled Medical Devices Approved Via Expedited FDA Process
The majority of medical devices recalled in recent years because of serious health risks were cleared through a quicker FDA approval system that does not require testing on patients, according to a recent a recent study published in the Archives of Internal Medicine, the Wall Street Journal reports (Mundy/Kamp, Wall Street Journal, 2/15).
The approval system, known as 510(k), is quicker and less costly for device makers. Devices are eligible for the 510(k) system if FDA deems them similar to devices already on the market. Typically, novel devices face a longer, more costly path to approval.
Researchers at the National Research Center for Women and Families examined medical devices that were recalled from 2005 to 2009 for serious or life-threatening problems (Richwine, Reuters, 2/14). They found that 80 out of 113 recalled devices, or 71%, were cleared through the 510(k) process. In addition, 12% of the recalled devices approved through the expedited system were marketed for "risky indicators" that, under federal law, warrant a full review before going on the market, Modern Healthcare reports (McKinney, Modern Healthcare, 2/14).
Diana Zuckerman -- leader author of the study and head of NRCWF -- said, "These findings suggest that reform of the regulatory process is needed to ensure the safety of medical devices."
However, FDA spokesperson Karen Riley said the recalls "donât reflect the thousands of people who have benefited from these devices." She added that it is "not surprising" that most of the recalled devices went through the 510(k) process because most products are cleared that way.
The Advanced Medical Technology Association, the industry's lobbying group, suggested that the study is flawed because it does not compare the number of recalled devices with the number of devices that have had no problems. Studies supported by the group have found that more than 99% of devices cleared through the 510(k) system are never recalled (Wall Street Journal, 2/15).
Meanwhile, on the same day of the release of the study, FDA issued a final rule easing the approval process for certain hardware and software products used with medical devices (Modern Healthcare, 2/14).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.