---
kind: "range"
citation: "42 C.F.R. §§ 405.203–405.207"
title: "42"
from: "405.203"
to: "405.207"
count: 3
url: "https://uscodex.org/cfr/42/405.203..405.207"
---

# §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.**

# §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.

# §405.207. Services related to a noncovered device.

- (a) **When payment is not made.** Medicare payment is not made for medical and hospital services that are related to the use of a device that is not covered because CMS determines the device is not “reasonable” and “necessary” under section 1862(a)(1)(A) of the Act or because it is excluded from coverage for other reasons. These services include all services furnished in preparation for the use of a noncovered device, services furnished contemporaneously with and necessary to the use of a noncovered device, and services furnished as necessary after-care that are incident to recovery from the use of the device or from receiving related noncovered services.
- (b) **When payment is made.** Medicare payment may be made for—
  - (1) Covered services to treat a condition or complication that arises due to the use of a noncovered device or a noncovered device-related service; or
  - (2) Routine care items and services related to Category A (Experimental) devices as defined in [§ 405.201(b)](/cfr/42/405.201.md?p=b), and furnished in conjunction with FDA-approved clinical studies that meet the coverage requirements in [§ 405.211](/cfr/42/405.211.md).
  - (3) Routine care items and services related to Category B (Nonexperimental/investigational) devices as defined in [§ 405.201(b)](/cfr/42/405.201.md?p=b), and furnished in conjunction with FDA-approved clinical studies that meet the coverage requirements in [§ 405.211](/cfr/42/405.211.md).