---
kind: "section"
citation: "42 C.F.R. § 405.203"
title: "42"
number: "405.203"
heading: "FDA categorization of investigational devices."
url: "https://uscodex.org/cfr/42/405.203"
---

# §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.**

## Notes

### 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