Code of Federal Regulations (Last Updated: July 5, 2024) |
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 |
§ 405.203 - FDA categorization of investigational devices.
Latest version.
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§ 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