GroundRules
42 CFR 405.205: Coverage of a Category B (Nonexperimental/investigational) device.
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) 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.
Collected 2026-08-27T02:26:11Z. Source file · JSON