42 CFR 405.203 – FDA categorization of investigational devices
Current as of: 2024 | Check for updates
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(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.