42 CFR § 405.203 - FDA categorization of investigational devices.

---
identifier: "/us/cfr/t42/s405.203"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "42 CFR § 405.203 - FDA categorization of investigational devices."
title_number: 42
title_name: "Public Health"
section_number: "405.203"
section_name: "FDA categorization of investigational devices."
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"
---


# 405.203 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