§814.102. Designation of HUD status. — Inbound Citations

(1) A copy of or reference to the determination made by FDA's Office of Orphan Products Development (in accordance with § 814.102) that the device qualifies as a HUD;

(a) An applicant seeking a new indication for use of a HUD approved under this subpart H shall obtain a new designation of HUD status in accordance with § 814.102 and shall submit an original HDE in accordance with § 814.104.

(2) This action will ensue if the request is incomplete because it does not on its face contain all of the information required under § 814.102(a). Upon receipt of this additional information, the review period may be extended up to 45 days; or

(i) An update of the information required under § 814.102(a) in a separately bound volume;

(9) The device's HUD designation should be revoked in accordance with § 814.102(c).