GroundRules
42 CFR 405.203: FDA categorization of investigational devices.
Where this section sits in the code
- Title 42—Public Health
- CHAPTER IV—CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER B—MEDICARE PROGRAM
- PART 405—FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED
- Subpart B—Medical Services Coverage Decisions That Relate to Health Care Technology
(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.
Collected 2026-08-27T02:26:11Z. Source file · JSON