21 CFR 814.108 - Supplemental applications.

§ 814.108 Supplemental applications.

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.

[ 63 FR 59220, Nov. 3, 1998]

Title 21 published on 09-Jun-2018 03:51

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 814 after this date.

  • 2018-02-21; vol. 83 # 35 - Wednesday, February 21, 2018
    1. 83 FR 7366 - Human Subject Protection; Acceptance of Data From Clinical Investigations for Medical Devices
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule.
      This rule is effective February 21, 2019. See section III of this document for additional explanation of the effective date of this final rule.
      21 CFR Parts 807, 812, and 814
The section you are viewing is cited by the following CFR sections.