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  6. Center for Devices and Radiological Health's Response to Coronavirus (COVID-19): Infographic
  1. Coronavirus (COVID-19) and Medical Devices

Center for Devices and Radiological Health's Response to Coronavirus (COVID-19): Infographic

"If you want to know the U.S. Food and Drug Administration's impact on COVID-19, look no further than the numbers." Stephen M. Hahn, M.D., Commissioner of Food and Drugs

This infographic provides a visualization of data associated with CDRH's response to the coronavirus (COVID-19) pandemic.

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CDRH's response to COVID-19 infographic

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Center for Devices and Radiological Health's Response to COVID-19

Timeline: January 1 - September 18, 2020

Regulatory Flexibility: Proactively issued policies to provide regulatory flexibility to address the pandemic

  • 10 EUA templates
  • 23 guidance documents
  • Including policies intended to help:
    • Car manufacturers making ventilators
    • Apparel manufacturers making masks
    • 3D printing making ventilator components

Emergency Use Authorizations: 516 medical products authorized under EUAs (almost 10x the number authorized in all prior national emergencies), including 248 tests, of which:

  • 198 are molecular tests
  • 4 are antigen tests
  • 46 are antibody tests

The FDA received

  • 1,734 pre-EUAs
  • 3,040 EUAs

Shortage Mitigation Activities: Outreach to 1,000+ manufacturing sites across 12 countries to access supply chain vulnerabilities. Result: Identified potential supply chain issues early and worked to minimize disruptions

Public Health Service Corps Deployment: 58 CDRH Commissioned Corps officers have been deployed 78 times in support of the COVID-19 mission.

Engagement with Stakeholders:

  • Sent 13.7 million emails to stakeholders on COVID-19 topics
  • Responded to 337,000 email and phone queries from patients, health care personnel, industry, and others
  • Hosted 39 COVID-related webinars and townhalls with 36,000+ participants

For more information, please visit fda.gov/medical-devices.

 

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