FDA Today Continued to Take Action in the Ongoing Response Effort to the COVID-19 Pandemic

Tuesday, July 14, 2020
  • Today, the FDA issued an immediately in effect guidance Notifying the Center for Devices and Radiological Health of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the Federal Food, Drug, and Cosmetic Act During the COVID-19 Public Health Emergency. This guidance is intended to assist manufacturers in providing FDA timely, informative notifications about changes in the production of certain medical device products that will help the Agency prevent or mitigate shortages of such devices during the COVID-19 public health emergency. On May 11, 2020, the FDA will host a webinar for medical device manufacturers and others interested in learning more about the guidance.
  • Diagnostics update to date:
    • During the COVID-19 pandemic, the FDA has worked with more than 385 test developers who have said they will be submitting EUA requests to the FDA for tests that detect the virus.To date, the FDA has issued 60 individual EUAs for test kit manufacturers and laboratories. In addition, 25 authorized tests have been added to the EUA letter of authorization for high complexity molecular-based laboratory developed tests (LDTs).
    • The FDA has been notified that more than 240 laboratories have begun testing under the policies set forth in our COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance.
    • The FDA also continues to keep its COVID-19 Diagnostics FAQ up to date.

Additional Resources:

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