COVID-19 FDA Update

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:

• The FDA issued an emergency use authorization (EUA) for the Philips Medizin Systeme Boeblingen GmbH’s IntelliVue Patient Monitors MX750/MX850, IntelliVue 4-Slot Module Rack FMX-4 and IntelliVue Active Displays AD75/AD85, intended to be used by healthcare professionals in the hospital environment for remote monitoring of adult, pediatric and neonate patients having or suspected of having COVID-19 to reduce healthcare provider exposure. The IntelliVue Patient Monitors are not intended for home use. The remote monitoring capabilities of the Philips IntelliVue Patient Monitors reduce the amount of contact by healthcare providers with patients during the COVID-19 pandemic who are in isolation rooms, thereby reducing the healthcare providers’ risk of exposure to the virus.
• The FDA and Federal Trade Commission issued a warning letter to a seller of fraudulent COVID-19 products, as part of the agency’s effort to protect consumers. The seller warned, Copper Touch, LLC, offers unapproved and misbranded products including “Sani-Bar GK95” and “Sani-Disc GK95D” for sale in the U.S. with misleading claims that the products are safe and/or effective for the prevention and treatment of COVID-19. There are currently no FDA-approved products to prevent or treat COVID-19. Consumers concerned about COVID-19 should consult with their health care provider.
• The FDA issued a guidance explaining a temporary policy regarding the repackaging or combining of FDA-approved propofol injectable emulsion, 10 mg/ mL (propofol) products, for the treatment or management of hospitalized patients during the COVID-19 public health emergency. This guidance provides regulatory flexibility for state-licensed pharmacies (including hospital pharmacies), federal facilities and outsourcing facilities that repackage or combine FDA-approved propofol products for hospitals that are having difficulty obtaining adequate supplies of the FDA-approved version in the sizes they use to support or treat patients with COVID-19.
• Diagnostics update to date:
  • During the COVID-19 pandemic, the FDA has worked with more than 360 test developers who have said they will be submitting emergency use authorizations (EUA) requests to FDA for tests that detect the virus.
  • To date, the FDA has issued 43 individual emergency use authorizations for test kit manufacturers and laboratories. In addition, 17 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 215 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:

• Coronavirus Disease 2019 (COVID-19)