Center for Devices and Radiological Health’s (CDRH) Response to Coronavirus (COVID-19)

Timeline: January 1 – September 18, 2020

  • Regulatory Flexibility: EUA templates, guidance documents, policies
  • Emergency Use Authorizations: 10x medical devices the number authorized pre-2020, tests
  • Shortage Mitigation Activities: Outreach to 1,000+ manufacturing sites across 12 countries
  • Public Health Service Corps Deployment: 58 CDRH Commissioned Corps officers
  • Engagement with Stakeholders: Emails, phine queries, webinars, townhalls

fda.gov/medical-devices

Patient Outreach Toolkit

Useful COVID-19 resources for healthcare professionals to share with patients

Fraudulent Products Factsheet
(English / Español – PDF, 1.2MB)

FDA Response to COVID-19: What You Need to Know Infographic
(English / Español – PDF, 4.4MB)

Approved COVID-19 Tweets
(English / Español – PDF, 1.6MB)

A Culture of Responsibility: Laboratory Safety at the FDA

In observance on NIH’s Biosafety & Biosecurity Month, FDA is implementing the folloiwng in its labs

  • Proper use of PPE (masks, face shields, gloves, gowns, shoe covers)
  • Engineering controls (biosafety cabinets, secure rooms)
  • Administrative controls (risk assessment, pre-work approval, medical surveillance, respiratory protection programs)
  • Best practices for decontaminating surfaces and proper procedures for packing and transporting any hazardous biomaterials, including SARS-CoV-2

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Industry Guidance: Emergency Use Authorization for
Vaccines to Prevent COVID-19

Data and information needed for Emergency Use Authorization (EUA) for an investigational COVID-19 vaccine that could be potentially administered to millions of individuals

  • Chemistry, manufacturing, and controls information (CMC); nonclinical data and information; and clinical data and information, as well as administrative and regulatory information

Safety and Effectiveness Information for evaluation of benefit-risk profile

  • Bioassays for assessment of clinical endpoints
  • Supportive nonclinical studies e.g., characterization of markers associated with enhanced disease, biodistribution, shedding, and attenuation)
  • Clinical
    a. Prespecified success criteria for primary efficacy endpoint (previous guidance), placebo controlled efficacy trial of at least 50%
    b. All safety with focus on serious adverse events, adverse events of special interest, and cases of severe COVID-19 among study subject
    c. Data from Phase 3 studies should include a median follow-up duration of at least two months after completion of the full vaccination regimen
  • In addition
    a. Local and systemic solicited adverse reactions for reactogenicity
    b. All safety data from database lack, n> 3,000
    c. Sufficient cases of severe COVID-19 among study subjects
    d. Sufficient cases of individuals with prior SARS-CoV-2 infection

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Cellular signaling and immune correlates for SARS-CoV-2 infection

Research award to Stanford University to help inform the development and FDA review of COVID-19 medical countermeasures

  • Explain host factors contributing to coronavirus immune responses to more rapidly predict patient outcomes
  • Innovative in-depth analysis of existing tissue samples from previous clinical and nonclinical studies
  • Profile circulating immune signatures of coronavirus infection, pathology, tissue imaging, tissue viral reservoirs, how different systems in the body are affected

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Image credit: FDA, Stanford University

Published by Drug & Device Advisory Group