Investigational device exemption (IDE) refers to an FDA-approved IDE application that permits a device, which would otherwise be subject to marketing approval or clearance, to be shipped lawfully for the purpose of conducting a clinical study in accordance with 21 U.S.C. 360j and 21 CFR part 812.
42 CFR § 405.201
Scope. This subpart establishes that -
(1) CMS uses the FDA categorization of a device as a factor in making Medicare coverage decisions; and
(2) CMS may consider for Medicare coverage certain devices with an FDA-approved investigational device exemption (IDE) that have been categorized as Category B (Nonexperimental/investigational) device.
(3) CMS identifies criteria for coverage of items and services furnished in IDE studies.