42 C.F.R. § 405.203 FDA categorization of investigational devices.
Title 42 - Public Health
(a) The FDA assigns a device with an FDA-approved IDE to one of two categories: (1) Experimental/Investigational (Category A) Devices. (2) Non-Experimental/Investigational (Category B) Devices. (b) The FDA notifies CMS, when it notifies the sponsor, that the device is categorized by FDA as experimental/investigational (Category A) or non-experimental/investigational (Category B). (c) CMS uses the categorization of the device as a factor in making Medicare coverage decisions.
Title 42: Public Health
PART 405—FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED
Subpart B—Medical Services Coverage Decisions That Relate to Health Care Technology
§ 405.203 FDA categorization of investigational devices.
