Similar Recall Rates Perhaps the strongest evidence to surface in recent weeks that the FDA&rsquo

Similar Recall Rates

Perhaps the strongest evidence to surface in recent weeks that the FDA’s heavy-handed methods haven’t paid off in terms of improving public safety comes from a January 2011 study by the Boston Consulting Group (BCG) showing highly similar rates of medical device recalls (termed Field Safety Corrective Actions in the E.U.) in the United States and Europe, despite the FDA’s more complex and rigorous clearance and approval processes. The study’s investigators claim the results indicate the EU’s faster approval process does not compromise public safety.

The study, sponsored by the medical device industry lobbying group Advanced Medical Technology Association (AdvaMed), is, however, not without artifacts. Investigators themselves acknowledged that recall data comparisons between the highly centralized U.S. regulatory system and the more dispersed European system (with Competent Authorities in each member state) are less than airtight, and recall data from France—one of the EU’s largest markets—was not available. Nonetheless, taken in context with the Stanford and PwC research, the BCG/AdvaMed study seems to further demonstrate the need for a more efficient, time- and cost-sensitive regulatory approach to medical devices by the FDA.