The 2013 Medical Device Tax - Impact of the New Tax on the Marketing and Sale of Human and Veterinary Medical Devices in the U.S. Today
Tuesday, June 11, 2013 from 10:00 AM to 11:00 AM (PDT)
Palo Alto, CA
This webinar will provide a comprehensive overview of the 2013 Medical Device Excise Tax (Medical Device Tax) and its applicability to medical devices intended for marketing and sale in the U.S.
Why Should You Attend:
The Medical Device Tax applies to any medical device falling within the definition of a device in Section 201(h) of the Federal Food, Drug, & Cosmetic Act ("FDCA"). The FDCA defines the term "device" very broadly to include instruments, machines, implants and in vitro reagents, among others. For the tax to apply, the device must be marketed and sold for use in humans.
This webinar will provide a comprehensive overview of the application of the new Medical Device Excise Tax. It will also examine Congressional efforts to repeal the tax that was meant to help pay for $29 billion of the costs of the new healthcare law or Affordable Care Act of 2010.
Attendees will also learn how FDA defines the term "medical device" and its system for regulating such products in the U.S. market. The applicability of the Medical Device Tax to veterinary devices will also be discussed. This will include a discussion of what distinguishes a veterinary device from a device intended for human use.
There is however a variety of recognized exceptions from the new Medical Device Tax including devices exported or destined for export; components intended for further manufacture; devices intended exclusively for veterinary use; and items purchased by the general public at retail for individual use. These exceptions will be reviewed during the presentation.
- Gain a basic understanding of the scope and applicability of the new Medical Device Tax
- Learn how the FDA defines and regulates a "medical device" and understand the types of devices subject to the new tax
- Become familiar with the provided exceptions to the Medical Device Tax while learning the types of devices to which the tax does not apply
- Learn what constitutes a "taxable medical device" for purposes of the tax
- Recognize who is responsible for paying the tax and how it is levied
- Determine its impact on veterinary medical devices
- Learn the arguments for and against maintaining the new tax. Understand the current status of the tax and Congress' efforts to repeal it
Areas Covered in the Webinar:
- The new 2013 Medical Device Excise Tax
- The Federal Food, Drug, and Cosmetic Act's definition of a "medical device"
- The regulatory distinction between a human medical device and a veterinary medical device
- The concept of the "taxable medical device"
- Who must pay the tax and what criteria does the IRS apply for levying the tax
- Strategies for incorporating the new tax into business decisions
- The arguments being made by defenders and opponents of the tax.
When & Where
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