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Publication 510
taxmap/pubs/p510-040.htm#en_us_publink1000306827

Taxable Medical Devices(p34)

rule
taxmap/pubs/p510-040.htm#en_us_publink1000302056

Taxable medical devices.(p34)

rule
The tax on the sale of certain medical devices by the manufacturer, producer, or importer of the device is 2.3% (.023) of the sales price. A taxable medical device is a device that is listed as a device with the Food and Drug Administration (FDA) under section 510(j) of the Federal Food, Drug, and Cosmetic Act and 21 CFR part 807, pursuant to FDA requirements. There are specific exemptions for eyeglasses, contact lenses, and hearing aids. There is also an exemption for devices that are determined by the Secretary to be of a type that are generally purchased by the general public at retail for individual use (this exemption is known as the retail exemption). See T.D. 9604 for information on how to determine whether a device falls within the retail exemption, and examples of how a taxpayer might evaluate a given device.
taxmap/pubs/p510-040.htm#en_us_publink1000302057

More information.(p34)

rule
For more information on the medical device tax, see section 4191, T.D. 9604, and Notice 2012-77. You can find T.D. 9604 and Notice 2012-77 on pages 730 and 781, respectively, of I.R.B. 2012-52 at www.irs.gov/pub/irs-irbs/irb12-52.pdf.