FDA categorization of investigational devices.

  1. Law
  2. CFR 42
  3. Public Health
  4. Centers for Medicare & Medicaid Services, Department of Health and Human Services
  5. Medicare Program
  6. Federal Health Insurance for the Aged and Disabled
  7. Medical Services Coverage Decisions That Relate to Health Care Technology
  8. FDA categorization of investigational devices.

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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


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