Proposed Legislation Seeks to Improve FDA Regulatory Process for Medical Devices

October 13, 2011—United States Senators Amy Klobuchar (D-MN), Richard Burr (R-NC), and Michael Bennet (D-CO) announced the introduction of legislation that seeks to help boost medical innovation by reducing regulatory burdens that unnecessarily delay beneficial new medical products from reaching patients. The senators stated that the Medical Device Regulatory Improvement Act would help to streamline the US Food and Drug Administration's (FDA) regulation of medical devices to continue to encourage innovation and get new lifesaving products on the market more quickly, without compromising consumer safety.

In a statement from the Advanced Medical Technology Association (AdvaMed), the medical device industry's Washington-based trade association, AdvaMed President and CEO Stephen J. Ubl commented, “AdvaMed applauds Senator Klobuchar, along with her cosponsors Senator Burr and Senator Bennet, for their bipartisan work on this important legislation that will help American patients to get timely access to life-saving, life-changing medical technology. We are especially encouraged to see the legislation's focus on clarifying FDA data requirements, streamlining agency management processes, and its emphasis on the importance of attracting the best experts to FDA advisory committees.”

Mr. Ubl added, “We support the legislation and commend the bill's sponsors for working to make the FDA review process more efficient and predictable, a key component of AdvaMed's Competitiveness Agenda. As the legislative process moves forward, we look forward to working with members of Congress on both sides of the aisle and with the FDA to ensure patients have timely access to safe and effective products.”

According to the senators, the FDA's regulation has become increasingly longer and more difficult during the past few years, delaying, and in some cases preventing, new and innovative devices from reaching the market. They cited recent studies showing that the average time to approve a 510(k) application has increased 43% from the 2003 to 2007 period to 2010, and the average time to approve a premarket approval application has increased 75%. They noted that a recent survey of venture capitalist life sciences investors showed that approximately 40% of investors are more likely to shift their operations and investments overseas because of the FDA's regulatory challenges.

The senators stated that the legislation would help streamline the FDA's regulation of medical devices by clarifying the FDA's current, least burdensome requirements. They believe that these provisions will ensure that when making regulatory decisions on medical devices, the FDA focuses only on the relevant information during the decision-making process; considers appropriate alternatives to reduce the time, effort, and cost of reaching regulatory decisions; and uses all reasonable mechanisms to reduce review times when making these decisions.

They further asserted that current conflicts-of-interest restrictions are overly stringent, resulting in the FDA having difficulty finding qualified experts to serve on advisory committees, which can contribute to unnecessary delays for patients. In response to this problem, the legislation would restore the appropriate balance to conflicts-of-interest requirements by requiring the FDA to be subject to the same conflicts-of-interest requirements as the rest of the federal government. Finally, the legislation would also direct the FDA to contract with an outside entity to conduct a thorough review of the management and regulatory processes at the FDA's Center for Devices and Radiological Health, including the impact on medical device innovation.

Senator Klobuchar is Chair of the Senate Commerce Subcommittee on Competitiveness, Innovation, and Export Promotion. She has been a leader in the effort to cut red tape that threatens innovation in the medical device industry and founded the bipartisan Senate Medical Technology Caucus to increase awareness about issues facing the industry. 

After a December 2010 report surveyed more than 200 medical technology companies and found that confusing and contradictory regulations are stifling innovation, Senator Klobuchar urged the FDA to reform its “slow and inconsistent” 510(k) approval process for medical devices to maintain safety, protect patients, and encourage innovation. When the FDA issued it Strategic Plan for Regulatory Science in August 2011, Senator Bennet sent a letter to FDA Commissioner Margaret Hamburg, calling for reform of FDA regulations to foster innovation and competitiveness.