1. 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 Publication: [Silver Spring, MD] : Center for Devices and Radiological Health, November 2, 2023 Subject(s): Compassionate Use TrialsDevice ApprovalGovernment RegulationGuideline AdherenceUnited States
