FDA Issues New Policy and posts FAQs on Viral Transport Media

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-viral-transport-media-during-coronavirus-disease-2019-covid-19-public-health?utm_campaign=2020-07-20%20Viral%20Transport%20Media%20COVID-19&utm_medium=email&utm_source=Eloqua

FDA Issues New Policy and Posts FAQs on Viral Transport Media For Use During the COVID-19 Emergency

Today, the U.S. Food and Drug Administration (FDA) issued an immediately in effect guidance intended to help expand the availability of transport media used to transport certain clinical specimens for testing during the COVID-19 public health emergency. The guidance describes the FDA’s policy for commercial manufacturers of viral transport media (VTM), sterile phosphate buffered saline (PBS), and sterile normal saline. In addition, the guidance describes the FDA’s policy for laboratories that meet requirements to perform high-complexity testing who develop and use transport media to transport certain clinical specimens for testing using molecular or antigen diagnostic assays during the public health emergency. Read the guidance The FDA also posted answers to frequently asked questions relating to the development and use of transport media during the COVID-19 public health emergency. Read the FAQs The FDA believes that the policies described in the guidance will help address public health concerns caused by shortages of transport media and help expand the availability of SARS-CoV-2 diagnostic tests. This policy reflects the FDA’s commitment to ease burdens on commercial manufacturers and clinical laboratories as they face the COVID-19 public health emergency.

Questions? If you have questions about this final guidance, contact CDRH-EUA-Templates@fda.hhs.gov.