StacksVerified U.S. regulatory reference

21 CFR §814.110

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (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. (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.