The IRS has issued rules and regulations that describe what constitutes a taxable medical device. The references are geared to language in the federal Food and Drug Act. For individuals, it is important to remember that many consumer medical devices are excluded from the tax. Expressly excluded under the ACA are eyeglasses, contact lenses and hearing aids. IRS rules and regulations also create a “retail exemption” for medical devices that are commonly purchased by consumers. These include items such as crutches, bandages, wheelchairs, and portable oxygen machines.
The manufacturer or importer is responsible for reporting and paying the tax. The IRS generally treats the manufacturer as the business that produces the medical device. An importer is the business that brings a medical device into the U.S.