21CFR814.108

§ 814.108 Supplemental applications.

Regulation Text

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.

Authority

21 U.S.C. 351,352,353,360,360c-360j,360bbb-8b,371,372,373,374,375,379,379e,379k-1,381.

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Related Guidelines (5)

Manufacturing Site Change Supplements: Content and Submission: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
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30-Day Notices, 135-Day Premarket Approval (PMA) Supplements and 75-Day Humanitarian Device Exemption (HDE) Supplements for Manufacturing Method or Process Changes: Guidance for Industry and FDA Staff (Status: Final)
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Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
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Enforcement Policy for Certain Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
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Transitional Enforcement Policy for Ethylene Oxide Sterilization Facility Changes for Class III Devices: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
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