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CFR > Title 42 - Public Health > CHAPTER IV—CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER B—MEDICARE PROGRAM (parts 405 to 426) > PART 405—FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED > SUBPART B—Medical Services Coverage Decisions That Relate to Health Care Technology (§405.201 to §405.215) > 405.203—FDA categorization of investigational devices.

CFR

405.203—FDA categorization of investigational devices.

(a) The FDA assigns a device with an FDA-approved IDE to one of two categories:
(1) Experimental/Investigational (Category A) Devices.
(2) Non-Experimental/Investigational (Category B) Devices.
(b) The FDA notifies CMS, when it notifies the sponsor, that the device is categorized by FDA as experimental/investigational (Category A) or non-experimental/investigational (Category B).
(c) CMS uses the categorization of the device as a factor in making Medicare coverage decisions.
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