§405.203. FDA categorization of investigational devices.
42 C.F.R. § 405.203
The FDA assigns a device with an FDA-approved IDE to one of two categories—
Category A (Experimental) devices.
Category B (Nonexperimental/investigational) devices.
The FDA notifies CMS, when it notifies the sponsor, that the device is categorized by FDA as Category A (Experimental) or Category B (Nonexperimental).
CMS uses the categorization of the device as a factor in making Medicare coverage decisions.
Notes, amendments, and revision history
Amendments
[60 FR 48423, Sept. 19, 1995, as amended at 78 FR 74809, Dec. 10, 2013
Authority
Authority: Secs. 1102, 1862 and 1871 of the Social Security Act as amended (42 U.S.C.1302, 1395y, and 1395hh).
Source
Source: 60 FR 48423, Sept. 19, 1995, unless otherwise noted.
Authority
Authority: 42 U.S.C. 263a, 405(a), 1302, 1320b-12, 1395x, 1395y(a), 1395ff, 1395hh, 1395kk, 1395rr, and 1395ww(k).
Amendments
[60 FR 48423, Sept. 19, 1995, as amended at 78 FR 74809, Dec. 10, 2013