Notice 2012-77 provides interim guidance on the tax treatment of convenience kits. Under the interim guidance, a taxable medical device that goes into a domestically-produced convenience kit will be subject to tax upon its sale by the manufacturer or importer, but the sale of the convenience kit by the kit producer will not be subject to tax. Special rules apply to imported kits.
For purposes of the notice, a convenience kit is a set of two or more devices within the meaning of § 201(h) of the Federal Food, Drug, and Cosmetic Act that is enclosed in a single package, such as a bag, tray, or box, for the convenience of a healthcare professional or the end user.
