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.