part_subject: "PREMARKET APPROVAL OF MEDICAL DEVICES"
subpart_code: "H"
subpart_subject: "Humanitarian Use Devices"
section_number: "814.110"
section_subject: "New indications for use."
cfr_reference: "21 CFR 814.110"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 800 to 1299"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
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(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.