Medical Device Excise Tax

Instructor: Daniel O Leary
Product ID: 703114
Training Level: Intermediate to Advanced
  • Duration: 90 Min

recorded version

1x Person - Unlimited viewing for 6 Months
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Recorded Link and Ref. material will be available in My CO Section

Training CD

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Read Frequently Asked Questions

This webinar explains the excise tax on medical device manufactures that went into effect on January 1, 2013, including the devices it covers and the effective selling price for tax purposes.

Why Should you Attend:

The medical device excise tax is effective as of January 1, 2013 and applies to medical devices listed with the FDA under Part 807. However, there are exemptions that could limit your tax exposure.

This webinar answers important questions about the excise tax.

  • Are all medical devices liable for the tax? Which ones are exempt?
  • Since the tax uses the price of the device, how do you determine the correct price for the tax?
  • When does the manufacturer make deposits and file forms?
  • Will IRS grant relief on penalties because the rules are unfamiliar?

As a bonus, participants will receive:

  • A copy of the regulations, formatted to read more easily
  • A sample worksheet to help determine if your device is taxable
  • A sample worksheet to help determine the effective sale price of a taxable device

Areas Covered in the Webinar:

  • The law that created the medical device excise tax
  • An explanation of a manufacturer’s excise tax
  • The basic requirement to pay the tax – listing a medical device under Part 807
  • The retail exemption for the tax
  • Exemptions based on device classification – the safe harbor
  • The facts and circumstances test, including device classification
  • Determining the effective sale price – the six IRS distribution chain models
  • Quarterly filing
  • Semi-monthly deposits
  • Granting relief on penalties

Who will benefit:

People in the following roles, in medical device companies, can especially benefit from the knowledge in this webinar:

  • Accounting and tax
  • Finance
  • Legal
  • Quality
  • Regulatory
  • Sales

Instructor Profile:

Daniel O Leary, is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.

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