• Dixey

Senator Marco Rubio, Reauthorization Medical Device User Fee & Modernization Act (MDUFMA)

Friday, February 10, 2012 12:17 PM

Dear Mrs. Dixey,

Thank you for taking the time to contact me regarding medical devices.  I understand that issues pertinent to medical devices affect millions of individuals who rely on medical devices for a number of health reasons, and I appreciate hearing your thoughts about this matter.  Our nation is home to the world’s most renowned health care innovators and professionals who are helping Americans lead longer and healthier lives every day, and medical devices play an important role in our nation’s health system.

The Food and Drug Administration (FDA) within the Department of Health and Human Services (HHS) holds the primary responsibility of protecting Americans from harmful substances, including drugs and vaccines, food, supplements, and medical devices, among other things.  The FDA’s Center for Devices and Radiological Health (CDRH) is the primary supervisory body for entities that manufacture, repackage, relabel, and/or import medical devices sold in the United States.

The Medical Device User Fee and Modernization Act (MDUFMA) was signed into law in 2002 in order to allocate resources to the FDA for the purpose of reviewing medical devices to ensure their safety and effectiveness.  The MDUFMA was reauthorized in 2007 by the Medical Device User Fee Amendments of 2007, but will expire on September 30, 2012.  The Senate Committee on Health, Education, Labor, and Pensions (HELP) has held a hearing on FDA User Fee legislation, and members of the Committee have expressed a bipartisan commitment to the reauthorization of this legislation.

Although I do not serve on the Senate HELP Committee, I will certainly keep your thoughts regarding medical devices and the MDUFMA in mind should the reauthorization ever come before the full Senate for a vote.  Again, thank you for contacting me about this matter, and I look forward to any thoughts or input you wish to share in the future.

Sincerely, Marco Rubio United States Senator

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