---
kind: "section"
citation: "42 C.F.R. § 405.205"
title: "42"
number: "405.205"
heading: "Coverage of a Category B (Nonexperimental/investigational) device."
url: "https://uscodex.org/cfr/42/405.205"
---

# §405.205. Coverage of a Category B (Nonexperimental/investigational) device.

- (a) For any device that meets the requirements of the exception at [§ 411.15(o)](/cfr/42/411.15.md?p=o) of this chapter, the following procedures apply:
  - (1) The FDA notifies CMS, when it notifies the sponsor, that the device is categorized by FDA as Category B (Nonexperimental/investigational).
  - (2) **CMS uses the categorization of the device as a factor in making Medicare coverage decisions.**
- (b) If the FDA becomes aware that a categorized device no longer meets the requirements of the exception at [§ 411.15(o)](/cfr/42/411.15.md?p=o) of this chapter, the FDA notifies the sponsor and CMS and the procedures described in [paragraph (a)(2)](#a-2) of this section apply.

## 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