Medical Devices
FEATURED RESEARCH, TESTIMONIES, AND ANALYSIS:
Weekly Checkup No. 010: Medical Device Excise Tax Claims Its First Victims
This past week, Stryker Corporation, one of the largest medical device companies in the world, announced that it would lay off 5 percent of its global workforce of over 20,000 employees by the end of 2012 in anticipation of the 2.3 percent medical device excise tax included in the PPACA. Stryker is a flourishing company: annual revenue has grown every year over the past decade including an 8.9 percent increase in sales between 2009 and 2010. This move by Stryker demonstrates that even highly successful companies will be significantly hurt by the medical device excise tax and although the tax does not go into effect until 2013, the reverberations are already being felt.
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ADDITIONAL RESEARCH, TESTIMONIES AND ANALYSIS:
Weekly Checkup No. 028: Job Losses and Reduced R&D for Med-Tech Companies
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.
Medical Device User Fee Act Primer
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 Industry Primer
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.
