|Courtesy of Boston Scientific|
The first step toward a better understanding of the tax is defining just what constitutes a medical device, and the IRS, like the FDA, defers to the Federal Food, Drug and Cosmetic Act, which, in Section 201(h), delves into medical devices.
The legal definition is, to the say the least, expansive; it lumps tongue depressors and bedpans in with implantable cardiac defibrillators and advanced radiography machines. The agency also includes in-vitro diagnostic kits under the umbrella. In the language of the law, a medical device is anything that is "intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of it's primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes."
Essentially, it's safe to assume that if a product is regulated by the agency and isn't food or a drug, it falls into the medical device category.
However, an FDA-defined medical device is not necessarily a "taxable medical device" in the eyes of the IRS. The majority of implants, imaging techs and diagnostics we cover in FierceMedicalDevices will almost certainly be subject to the 2.3% charge, but the IRS has also allotted some exemptions, detailed next.
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