§801.55. Request for an exception from or alternative to a unique device identifier requirement. — Inbound Citations

(b) Exceptions to the general rule of paragraph (a) of this section are provided by §§ 801.30, 801.45, and 801.128(f)(2), and § 801.55 provides a means to request an exception or alternative not provided by those provisions.

(d) FDA may, in its discretion, act as an issuing agency if we determine it is appropriate for us to do so in order to facilitate or implement an alternative granted under § 801.55 of this chapter.