21 CFR 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.
Title 21 published on 2015-12-03.
No entries appear in the Federal Register after this date, for 21 CFR Part 814.