42 C.F.R. § 405.203

Current through September 30, 2024
Section 405.203 - FDA categorization of investigational devices
(a) The FDA assigns a device with an FDA-approved IDE to one of two categories:
(1) Category A (Experimental) devices.
(2) Category B (Nonexperimental/investigational) devices.
(b) The FDA notifies CMS, when it notifies the sponsor, that the device is categorized by FDA as Category A (Experimental) or Category B (Nonexperimental).
(c) CMS uses the categorization of the device as a factor in making Medicare coverage decisions.

42 C.F.R. §405.203

60 FR 48423, Sept. 19, 1995, as amended at 78 FR 74809, Dec. 10, 2013