FEATURED RESEARCH, TESTIMONIES, AND ANALYSIS:
ADDITIONAL RESEARCH, TESTIMONIES AND ANALYSIS:
Tucked into the 2,700 page Affordable Care Act is a 2.3% tax on medical devices sold in the United States. Created to raise $20 billion over the next 10 years to help pay for the pricy provisions of the health reform law, the tax is having injurious effects across the medical device industry.
The Medical Device User Fee and Modernization Act (MDUFMA or MDUFA) is a set of agreements between the Food and Drug Administration (FDA) and the medical device industry to provide funds for the FDA to review medical devices. Every five years, MDUFA must be reauthorized with adjusted fees and new guidelines that aim to streamline the review process. Industry leaders and the FDA are currently in discussions on proposals to include in MDUFA III as MDUFA II is set to expire on September 30th 2012.
Medical device design and manufacturing is one of America’s last unique frontiers. This is an industry that provides breakthrough treatment options that lengthen and improve the quality of life for millions. Broadly, medical devices are instruments used for the diagnosis and treatment of conditions in patients. Medical devices vary greatly in complexity from toothbrushes to implantable pacemakers. The Food and Drug Administration’s Center for Device and Radiological Health (CDRH) branch is primarily responsible for the review and approval of medical devices.