Guidance Documents to Address the COVID-19 Pandemic

The FDA intends to periodically publish a consolidated Notice of Availability (NOA) announcing the availability of all COVID-19 related guidance documents issued during this relevant period.

 

FDA Guidance on Conduct of Clinical Trials of Medical Products (March 27, 2020)

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FDA Guidance on Ventilators and Accessories and Other Respiratory Devices (March 22, 2020)

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FDA Guidance on Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring (March 20, 2020)

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FDA Guidance on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements (March 20, 2020)

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NIH Guidance for Funded Clinical Trials and Human Subjects Studies Affected by COVID-19 (March 16, 2020)

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Food and Drug Administration Website