StacksVerified U.S. regulatory reference

42 CFR §405.203

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (a)The FDA assigns a device with an FDA-approved IDE to one of two categories:
    1. (1)Category A (Experimental) devices.
    2. (2)Category B (Nonexperimental/investigational) devices.
  2. (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).
  3. (c)CMS uses the categorization of the device as a factor in making Medicare coverage decisions.