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Coronavirus (COVID-19) Update: Daily Roundup

Coronavirus (COVID-19) Update: Daily Roundup

Coronavirus (COVID-19) Update: Daily Roundup

PR Newswire

SILVER SPRING, Md., June 5, 2020 /PRNewswire/ -- The U.S. Food and Drug Administration today continued to take action in the ongoing response to the COVID-19 pandemic:

Additional Resources:

Media Contact: Lee.Herring@fda.hhs.gov, 240-402-6386
Consumer Inquiries: 888-INFO-FDA

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

 

 

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SOURCE U.S. Food and Drug Administration

  • The FDA is changing the hours for the COVID-19 Industry Hotline (1-888-INFO-FDA, press *). To best meet current needs, the Hotline operate from 8:00 a.m. to 8:00 p.m. Eastern Time, Monday through Friday. For urgent inquiries, the FDA Emergency Line (1-866-300-4374) remains available after-hours. The FDA has also published and continues to update extensive resources on COVID-19 and medical devices to help answer questions.
  • Effective immediately, new guidance issued by the FDA expands the availability and capability of non-invasive monitoring devices. These remote devices facilitate patient monitoring while reducing patient and healthcare provider contact and exposure to COVID-19 for the duration of the COVID-19 public health emergency. This guidance replaces the March 20, 2020, guidance, titled "Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency." The new guidance expands the scope to include additional device types (product codes) and provides additional references and standards for consideration.
  • Testing updates:
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