§ 814.110. New indications for use.
70 words·~1 min read·
/us/cfr/t21/s§ 814.110·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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.
(b)An application for a new indication for use made under § 814.104 may incorporate by reference any information or data previously submitted to the agency under an HDE.