Silver Spring, MD – The U.S. Food and Drug Administration (FDA) has announced the following actions taken in its ongoing response effort to the COVID-19 Coronavirus pandemic:
Thursday, the FDA issued a guidance on non-invasive fetal and maternal monitoring devices [1] to help increase the availability and capability of these devices used to support patient monitoring during the COVID-19 Coronavirus pandemic.
[2]Coronavirus
These prescription devices include fetal dopplers that lay users (such as patients or caregivers) could be instructed to use in a home setting under the direction of a health care provider as well as other fetal and maternal monitoring devices that could be used by a health care provider in a home setting.
Increasing the availability of these devices may increase access to important prenatal data without the need for in-clinic visits and facilitate patient management by health care providers while reducing the need for in-office or in-hospital services during the COVID-19 Coronavirus public health emergency.
Today, the FDA issued a guidance [3] to help increase availability and capability of imaging systems needed for diagnosis and treatment monitoring of lung disease in patients during the COVID-19 Coronavirus pandemic. These imaging products include medical x-ray, ultrasound, magnetic resonance imaging systems, and image analysis software that are used to diagnose and monitor medical conditions.
Increasing the availability of mobile and portable imaging systems may increase options to image patients inside and outside of healthcare facilities, which could help to reduce the spread of COVID-19 Coronavirus.
The FDA issued guidance [4] to communicate its temporary policy regarding certain requirements under the FDA Food Safety Modernization Act Accredited Third-Party Certification Program for foreign food entities and their products.
The guidance addresses the current challenges with conducting onsite monitoring activities during the COVID-19 Coronavirus public health emergency by providing temporary flexibility so that recognized accreditation bodies (ABs) can maintain the accreditations of certification bodies (CBs), and so that already-issued certifications need not lapse, where certain safeguards are in place. See constituent update [5] for more.
The FDA’s Best Practices for Retail Food Stores, Restaurants, and Food Pick-Up/Delivery Services During the COVID-19 Pandemic [6], is now available in Spanish [7].
Diagnostics update to date:
- During the COVID-19 Coronavirus 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 44 individual emergency use authorizations [8] for test kit manufacturers and laboratories. In addition, 18 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 220 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 [9] up to date.
Additional Resources:
Consumer Inquiries: 888.INFO.FDA
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About the U.S. Food and Drug Administration
The U.S. Food and Drug Administration (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.