42 CFR § 405.205 - Coverage of a Category B (Nonexperimental/investigational) device.

---
identifier: "/us/cfr/t42/s405.205"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "42 CFR § 405.205 - Coverage of a Category B (Nonexperimental/investigational) device."
title_number: 42
title_name: "Public Health"
section_number: "405.205"
section_name: "Coverage of a Category B (Nonexperimental/investigational) device."
chapter_name: "CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "B"
subchapter_name: "MEDICARE PROGRAM"
part_number: "405"
part_name: "FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "42 U.S.C. 263a, 405(a), 1302, 1320b-12, 1395x, 1395y(a), 1395ff, 1395hh, 1395kk, 1395rr, and 1395ww(k)."
cfr_part: "405"
---


# 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) 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) of this chapter, the FDA notifies the sponsor and CMS and the procedures described in paragraph (a)(2) of this section apply.

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