COVID-19-Related FDA Guidance Documents

  • Providing timely recommendations, regulatory information, guidance, and technical assistance necessary to support rapid response efforts
  • Anticipates to immediately implement  guidances
  • Will consider comments received and update as appropriate

Current List includes:

  • Manufacture of Alcohol for Alcohol-Based Hand Sanitizer Products
  • REMS Requirements
  • Ventilators and Accessories and Other Respiratory Devices
  • Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring
  •  Preparation of Certain Alcohol-Based Hand Sanitizer Products
  • Postmarketing Adverse Event Reporting
  • Conduct of Clinical Trials of Medical Products
  • Food Supplier Verification Onsite Audit Requirements
  • Diagnostic Tests
  • Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products