Supplemental applications.

21 C.F.R. § 814.108
in effectEffective: 2024-07-01
Sign in to generate a plain English summaryAsk Belisarius Agent
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.

Starting a business? Corpus forms LLCs in all 50 states and DC.