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]