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Friday, July 29, 2011

DeLauro weighs in on medical device testing

U.S. Rep. Rosa L. DeLauro, D-3, this afternoon issued a letter she wrote to the commissioner of the Food and Drug Administration, Dr. Margaret Hamburg, castigating the agency for not heeding a report calling for better testing of medical devices (see previous entry). Here's the text of DeLauro's letter.

July 29, 2011

Margaret Hamburg, M.D.


U.S. Food and Drug Administration

U.S. Department of Health and Human Services

10903 New Hampshire Ave

Silver Spring, MD 20993-0002

Dear Commissioner Hamburg:

I write to underscore my continued concern about the Food and Drug Administration’s (FDA) medical device approval and post-market surveillance and the agency’s response to a new review of that process.

The number of Americans that are affected by the safety and effectiveness of medical devices, specifically those that are life-sustaining or intended to be permanent implants, continues to increase. More than three-quarters of a million Americans have a hip or knee replaced each year. And more than half of the top five elective inpatient procedures reimbursed by Medicare in FY2006 included the insertion or repair of a medical device – a list that included both a hip or knee replacement and the repair of a previous hip or knee replacement.

Earlier today, the Institute of Medicine (IOM) released its findings on the 510(k) clearance process. The FDA requested this IOM review in 2009, and yet – on the very day the requested report has been released— FDA officials appear to have already reached a conclusion about the value and implementation of the report and its recommendations.

I am astonished that the agency tasked with protecting the public health may have already determined that the IOM recommendations cannot be implemented. The committee’s recommendations warrant meaningful consideration by the agency and advocates for both consumers and industry. They are clearly intended to better protect the public health by ensuring that the medical devices available are safe, effective, and appropriately monitored after approval.

A series of Government Accountability Office (GAO) studies and findings over the years clearly illustrate that the 510(k) process does not optimally protect the public health and needs to be reformed. Just this year, the FDA announced a series of changes and proposed changes to the 510(k) process based on identified shortfalls of the current inadequate process. Yet, as the IOM review clearly reinforces, there are fundamental concerns with the framework of the process that must be addressed if we are to truly protect the public health by ensuring the safety and efficacy of medical devices. A comprehensive review of medical devices, including both pre-market and post-market surveillance, is needed.

The questions and recommendations posed to the agency by the IOM are critical if Congress is to use the opportunity to review the Medical Device User Fee and Modernization Act as an opportunity to make the updates that are desperately needed to ensure the safety and effectiveness of medical devices.

Again, I strongly urge you to consider the IOM findings and recommendations as the agency continues to evaluate the approval and post-market surveillance of medical devices.

Thank you for your attention to this critical public health issue. I look forward to our continued work to protect the health of Americans.



Member of Congress


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