Senate Bill Seeks to Reinforce Least Burdensome Provisions for Medical Device Review

Nov 02, 2011   

On October 13, 2011, Senator Amy Klobuchar introduced a bill before the United States Senate, entitled the “Medical Device Regulatory Improvement Act.” Found here, the bill is aimed at amending the Federal Food, Drug and Cosmetic Act (FDCA) in an effort to increase efficiency in the way medical devices are reviewed by the U.S. Food and Drug Administration (FDA). In particular, the bill seeks to require the FDA to consider alternative ways of determining device safety and effectiveness, by requiring the agency to consider “alternatives to randomized, controlled clinical trials, such as the use of surrogate endpoints.” Additionally, the bill states that the FDA “shall not request information unrelated or irrelevant to a demonstration of reasonable assurance of device safety and effectiveness.” While the FDA often requests that manufacturers provide clinical data and other documentation under what it characterizes as “related to safety and effectiveness,” it is unclear how the bill would change the way the FDA reviews medical devices in practice.

As we previously reported, another bill proposing to change the way medical devices are reviewed was recently introduced before the U.S. House of Representatives. Similar to the bill proposed by Senator Klobuchar, the House bill is aimed at increasing the efficiency of FDAs review process. However, the Senate bill differs inasmuch as it focuses primarily on expediting review for devices following the premarket approval (PMA) and 510(k) clearance pathways. Although the “Least Burdensome” provisions – the portion of the FDCA that the Senate bill seeks to change – have been in place since the passage of the FDA Modernization Act of 1997, many in the industry have found that the provisions have little effect on the FDA review process. Thus, many are hoping that the passage of the Senate bill will lead to greater efficiency by lessening the burden on manufacturers during the medical device review process.

These proposals to update FDAs medical device review process are largely a result of the report recently released by the Institute of Medicine (IOM). Published on July 29, 2011, the IOM Report contained various recommendations for the FDA in relation to its medical device review process. As we previously reported, the IOM particularly took issue with FDAs 510(k) review process, recommending that the system undergo a complete overhaul.

Fuerst Ittleman will continue to monitor the developments and changes to FDAs medical device review process. For more information, please contact us at