- For Immediate Release:
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 updated FDA COVID-19 Response At-A-Glance Summary that provides a quick look at facts, figures and highlights of the agency's response efforts.
- 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:
- During the COVID-19 pandemic, the FDA has worked with more than 400 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 124 tests under EUAs, which include 106 molecular tests, 17 antibody tests, and 1 antigen test.
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.
- Lee Herring