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42 CFR 405.203 : Public Health (Part 1 To Parts 1009-1099) — (Subpart A To § 413.355) — Centers For Medicare & Medicaid Services, Department Of Health And Human Services (Subpart A To § 413.355) — Medicare Program (Subpart A To § 413.355) — Federal Health Insurance For The Aged And Disabled (Subpart A To § 405.2472) — Medical Services Coverage Decisions That Relate To Health Care Technology (§ 405.201 To § 405.215) — FDA categorization of investigational devices.

4 Aug 2016

(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 CFR 405.203
[60 FR 48423, Sept. 19, 1995, as amended at 78 FR 74809, Dec. 10, 2013