21 C.F.R. § 814.108
Current through May 31, 2024
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.
21 C.F.R. §814.108