21 C.F.R. § 814.110 – New indications for use. | Midpage
§ 814.110
21 C.F.R. § 814.110
New indications for use.
(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.