Code of Federal Regulations Title 42. Public Health § 42.405.205 Coverage of a Category B (Nonexperimental/investigational) device

(a) For any device that meets the requirements of the exception at § 411.15(o) of this chapter, the following procedures apply:

(b) If the FDA becomes aware that a categorized device no longer meets the requirements of the exception at § 411.15(o) of this chapter, the FDA notifies the sponsor and CMS and the procedures described in paragraph (a)(2) of this section apply.