Title 21: Food and Drugs
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/ PART 814 - PREMARKET APPROVAL OF MEDICAL DEVICES
/ Subpart H - Humanitarian Use Devices / § 814.108 Supplemental applications.
§ 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.