eCFR Reference Browser

---

title: "21 CFR §814.108"

source: "https://www.ecfr.gov/current/title-21/section-814.108"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "814"

part_subject: "PREMARKET APPROVAL OF MEDICAL DEVICES"

subpart_code: "H"

subpart_subject: "Humanitarian Use Devices"

section_number: "814.108"

section_subject: "Supplemental applications."

cfr_reference: "21 CFR 814.108"

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"

---

After FDA approval of an original HDE, an applicant shall submit supplements in accordance with the requirements for PMA's under § 814.39, except that a request for a new indication for use of a HUD shall comply with requirements set forth in § 814.110. The timeframes for review of, and FDA action on, an HDE supplement are the same as those provided in § 814.114 for an HDE.

§814.108 - Supplemental applications.