The medical device landscape is changing, due in large part to the controversial U.S. medical device excise tax that applies to American-made and imported medical devices. The tax has already taken effect, but it continues to draw controversy. The U.S. Senate recently passed a vote repealing the excise tax on medical devices, but a full repeal remains uncertain because the Senate vote was a nonbinding resolution. The Senate still needs to send a binding bill to the House to move forward.
Medical device companies are overwhelmingly against the medical device excise tax. A coalition composed of the Medical Imaging and Technology Alliance (MITA), the Medical Device Manufacturers Association (MDMA), and Advanced Medical Technology Association (AdvaMed) said the medical device tax hurts both patient access to medical technologies and the competitiveness of the U.S. medical device industry.
Most medical devices are covered by the new tax. In general those that are listed as a device with the Food and Drug Administration under section 510(j) of the Federal Food, Drug, and Cosmetic Act and 21 CFR Part 807 are covered, unless the device falls within the medical device excise tax exemption group. Among medical devices exempted from the excise tax are eyeglasses, contact lenses, and hearing aids.
This white paper ("How Medical Device Firms Can Adapt to New Excise Tax") tackles the issue that could potentially be a game changer for medical device companies. Those who can adapt to their new economic reality caused by the medical device excise tax will be able to redirect their efforts-in terms of innovation of products and improving daily operations-and enjoy continued success.
The white paper discusses the following:
For most medical device companies, adapting to the new federal medical device excise tax means doing more with less. Switching from a manual or hybrid QMS to a fully automated system is one way they can increase efficiency, reduce waste, and boost productivity without having to resort to further layoffs and R&D cuts.
MasterControl Inc., a software solutions provider that serves medical device firms and other life science and regulated industries, can help medical device companies do more with less and achieve the following:
To learn more about MasterControl and how we can help you overcome challenges with the medical device excise tax, please contact a MasterControl representative.
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