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Code of Federal Regulations

Subpart H

Humanitarian Use Devices

814.100Purpose and scope.814.102Designation of HUD status.814.104Original applications.814.106HDE amendments and resubmitted HDE's.814.108Supplemental applications.814.110New indications for use.814.112Filing an HDE.814.114Timeframes for reviewing an HDE.814.116Procedures for review of an HDE.814.118Denial of approval or withdrawal of approval of an HDE.814.120Temporary suspension of approval of an HDE.814.122Confidentiality of data and information.814.124Institutional Review Board requirements.814.126Postapproval requirements and reports.