42 CFR 405.203 - FDA categorization of investigational devices.

Regulations last checked for updates: Oct 31, 2024

Title 42 - Public Health last revised: Oct 29, 2024

View all text of Subpart B [§ 405.201 - § 405.215]

§ 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.

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

authority: 42 U.S.C. 263a,405,1302,1320b,1395x,1395y,1395ff,1395hh,1395kk,1395rr,and

cite as: 42 CFR 405.203