§814.104. Original applications. — Inbound Citations

(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.

(1) The application is incomplete because it does not on its face contain all the information required under § 814.104(b);

(ii) An update of the information required under § 814.104(b)(2), (b)(3), and (b)(5);

(ii) An update of the information required under § 814.104(b)(2), (b)(3), and (b)(5);

(ii) An update of the information required under § 814.104(b)(2), (b)(3), and (b)(5);