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FDA Coronavirus (COVID-19) Update

Summation

  • During the COVID-19 pandemic, the FDA has worked with more than 390 test developers who have already submitted or said they will be submitting EUA requests to the FDA for tests that detect the virus or antibodies to the virus.
  • The FDA announced that the agency will host a virtual Town Hall on May 15, 2020, for researchers, clinical laboratories, and commercial manufacturers to discuss the production and use of 3D printed swabs during the COVID-19 public health emergency.
  • Food and Drug Administration today continued to take action in the ongoing response effort to the COVID-19 pandemic.

The U.S. Food and Drug Administration today continued to take action in the ongoing response effort to the COVID-19 pandemic:

  • The FDA announced that the agency will host a virtual Town Hall on May 15, 2020, for researchers, clinical laboratories, and commercial manufacturers to discuss the production and use of 3D printed swabs during the COVID-19 public health emergency. This is a collaboration between the FDA, the Department of Veterans Affairs’ Innovation Ecosystem, and the National Institutes of Health’s 3D Print Exchange.
  • Today, the FDA posted a new webpage with information on use of thermal imaging systems. Thermal imaging systems and non-contact infrared thermometers use different forms of infrared technology to measure temperature. When used correctly, thermal imaging systems generally have been shown to accurately measure someone’s surface skin temperature without being physically close to the person being evaluated.
  • Testing updates:
    • During the COVID-19 pandemic, the FDA has worked with more than 390 test developers who have already submitted or said they will be submitting EUA requests to the FDA for tests that detect the virus or antibodies to the virus.
    • To date, the FDA has authorized 95 tests under EUAs, which include 82 molecular tests, 12 antibody tests, and 1 antigen test.

Other FDA News of Interest

Intuity Medical’s POGO Automatic®, the First and Only FDA-Cleared Automatic Blood Glucose Monitor, Now Covered by Medicare Part B

Intuity Medical, Inc., a medical technology company committed to making it easier to live with diabetes, announced today that its POGO Automatic® Blood Glucose...

XT-Thrive® Drug Master File (DMF) Accepted by the FDA | Reports X-Therma

X-Therma notes this DMF covers the Chemistry, Manufacturing and Controls (CMC) for this key chemistry innovation, which enables non-toxic cryopreservation for life-saving regenerative medicines.

Simpson Interventions Receives FDA Breakthrough Device Designation for Acolyte™ Image Guided Crossing and Re-Entry Catheter System

Simpson Interventions is committed to collaborating closely with the FDA and other stakeholders to advance the development and regulatory review of the Acolyte Image Guided Crossing and Re-Entry Catheter System. The company looks forward to bringing this revolutionary technology to clinicians, and patients in need.

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