21 C.F.R. · Food and Drugs
21 C.F.R. § 814.110

New indications for use.

Title 21 C.F.R. ● ACTIVE Primary Source
Regulatory Text

21 C.F.R. § 814.110 — New indications for use.

§ 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.

Source: ecfr.gov · govinfo.gov — public domain Official Source ↗
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21 C.F.R. § 814.110
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The regulatory text of 21 C.F.R. § 814.110 is reproduced from the official Code of Federal Regulations as published by the Office of the Federal Register and the National Archives and Records Administration.
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boisestandard.org United States Law CFR Title 21 21 C.F.R. § 814.110