21 C.F.R. § 814.108

Current through September 30, 2024
Section 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.

21 C.F.R. §814.108

63 FR 59220, Nov. 3, 1998