Feb 18, 2011

Business-friendly US lawmakers and the FDA’s Center for Devices and Radiological Health director Dr. Jeffrey Shuren squared off during a House of Representatives hearing on the regulator’s medical device review process. Echoing points made February 16th by Rep. Joe Pitts (R-Penn.), House Energy and Commerce Committee Chairman Fred Upton (R-Mich.) depicted the US medical device industry as losing ground to Europe due to burdensome and opaque FDA review methods. He made clear that a condition of Congressional reauthorization of the Medical Device User Fee Act setting user fees for premarket reviews in 2012 will be that the FDA “fix its problems”—specifically by building more certainty, predictability and transparency into its medical device review process. Remarkably similar points were made by the Advanced Medical Technology Association president and CEO Stephen Ubl, who stated, “One serious threat is the growing lack of predictability and consistency in product reviews at the FDA, which needlessly delays patient access to safe and effective diagnostics and treatments.” The CDRH’s Shuren countered in his testimony that 90% of the agency’s 510(k) reviews were completed in 90 days or less, and that 98% of those reviews were completed in 150 days or less. Shuren furthermore acknowledged some performance issues at the FDA, but attributed those issues to factors such as increasing workloads, key staff turnover, growing product complexity and poor quality of applicants’ submissions. “Although FDA is meeting its performance goals for 510(k)s, these submission quality problems delay the completion of the marketing clearance process and unnecessarily divert resources from more productive activities in the review process,” Shuren argued. As for recent studies comparing the US medical device regulatory system unfavorably to that of Europe, Shuren contended that significant differences between the two systems “confound comparisons.” He noted that EU regulators require no government review of a device before its marketing, nor any demonstration of a device’s effectiveness (instead, European regulators emphasize performance). Manufacturers are also allowed to “forum shop” among third-party reviewers subject to minimal oversight in the EU, a lack of centralized authority makes tracking product safety and regulatory performance data difficult. No doubt we’ll be hearing more of both sides’ talking points as the regulatory debate—now clearly with a legislative angle—continues.


  • Stewart Eisenhart