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