§814.110. New indications for use.
21 C.F.R. § 814.110
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.
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.
Notes, amendments, and revision history
Source
Source: 61 FR 33244, June 26, 1996, unless otherwise noted.
Authority
Authority: 21 U.S.C. 351, 352, 353, 360, 360c-360j, 360bbb-8b, 371, 372, 373, 374, 375, 379, 379e, 379k-1, 381.
Source
Source: 51 FR 26364, July 22, 1986, unless otherwise noted.