26 U.S. Code § 4191 - Medical devices

§ 4191.
Medical devices
(a) In general

There is hereby imposed on the sale of any taxable medical device by the manufacturer, producer, or importer a tax equal to 2.3 percent of the price for which so sold.

(b) Taxable medical deviceFor purposes of this section—
(1) In general

The term “taxable medical device” means any device (as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act) intended for humans.

(2) ExemptionsSuch term shall not include—
contact lenses,
hearing aids, and
any other medical device determined by the Secretary to be of a type which is generally purchased by the general public at retail for individual use.
References in Text

Section 201(h) of the Federal Food, Drug, and Cosmetic Act, referred to in subsec. (b)(1), is classified to section 321(h) of Title 21, Food and Drugs.

Prior Provisions

For prior sections 4191, 4192, 4201, and 4211, see Prior Provisions note set out preceding this section.

Effective Date

Pub. L. 111–152, title I, § 1405(c), Mar. 30, 2010, 124 Stat. 1065, provided that:

“The amendments made by this section [enacting this section and amending sections 4221 and 6416 of this title] shall apply to sales after December 31, 2012.”

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26 CFR - Internal Revenue



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