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

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