DeLauro Fights for Stronger FDA Regulation of Medical Devices

Washington, DC— Congresswoman Rosa DeLauro (CT-3), Chairwoman of the FDA and Agriculture Appropriations Subcommittee, issued the following statement today in support of the FDA reforming their approval process for medical devices.

"I strongly urge the FDA to continue their efforts to reform the 510(k) approval process for medical devices, and resist efforts by the industry to expedite the approval of potentially unsafe products. The American people would be shocked to learn that some in the industry believe that FDA should not have the authority to pull ineffective products from the market. Also, a recent Government Accountability Office (GAO) report confirmed that for years, high-risk medical devices, including implantable pacemakers, heart valves, and metal hip joints, were approved with minimal review to the industry's benefit.

"The days of FDA distorting science and being too lenient on industry are over. I agree with Commissioner Hamburg that the agency's responsibility is to take "science-based actions" to protect public health. We must ensure that high-risk medical devices, especially ones that are implanted into a patient's body, undergo stringent pre-market review before they are made available to patients."