§ 814.108 Supplemental applications.
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Title 21 CFR: Food and Drugs › Chapter I: FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › Part 814: PREMARKET APPROVAL OF MEDICAL DEVICES › Subpart H: Humanitarian Use Devices › § 814.108: § 814.108 Supplemental applications.
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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]
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