New GAO Report Finds Fault with FDA Recall Oversight

By Mike Rozembajgier

A new Government Accountability Office report (GAO) on the Food and Drug Administration’s (FDA) oversight of the medical device industry’s recall management process finds that the agency is failing to efficiently regulate the medical device industry. While the FDA oversees recalls of about 700 devices each year, the GAO report notes that the consumer agency could do a lot more to effectively assess whether those recalls have been effective.

The report is critical of the FDA’s lack of a comprehensive recall management strategy. Investigators argue that the FDA could do more with the data it collects from completed and ongoing recalls. According to the report, “more routine analysis of these data could help the FDA identify trends in the numbers and types of devices being recalled, as well as the underlying causes of device recalls.”

The vast majority of the recalls examined were of products approved through the FDA’s fast-tracked 510(k) approval process. The 510(k) process has been criticized by patient safety groups who are concerned over the speed and reliability of the review process, as well as by the medical device industry which considers the process to be inconsistent and unpredictable. A Northwestern University study of the 510(k) process notes that two-thirds of industry representatives surveyed are now planning to enter European markets before they come to the U.S., primarily because of the unpredictability associated with the fast-tracked FDA review. Over the past six years, 70 percent of all medical devices recalled were subject to the 510(k) approval process.

Among the recommendations in the GAO report are creating a program to routinely and systematically assess medical device recall information. The GAO suggests that this information would help the agency proactively identify strategies for mitigating the health risks associated with recalled products. Sen. Chuck Grassley (D-IA) echoed those recommendations in a news release issued after the release of the GAO report. According to Sen. Grassley, “Right now, it looks like the FDA is missing an opportunity to proactively identify and address risks presented by unsafe devices.  Doing so would establish greater accountability for patients.”

The GAO report goes on to recommend that the FDA enhance its oversight process by clarifying procedures for conducting medical device recall audit checks, developing explicit criteria for assessing whether firms have effectively managed the recall process, and documenting the agency’s rationale for closing out recalls.

As the FDA and concerned legislators continue to review and address the recommendations in the GAO report, medical device manufacturers should be getting ready to provide convincing documentation that their recalls are effective. Just as the FDA will be looking to analyze and assess past recalls to determine best practices, your company can learn from your own past recalls, and those of your competitors, just what recall management techniques work best. Now is the time to prepare your recall management team and test your recall plans so that you are ready when you suddenly have to initiate a recall.

Stericycle ExpertRECALL™ is the industry leader in recall logistics and regulatory compliance for consumer product, pharmaceutical, medical device, juvenile product, and food and beverage recalls. ExpertRECALL’s professionals are experts in recall management who can help you streamline the entire product recall process.