These Food and Drug Administration (FDA) developments came in this week:
FDA Reissues EUA for COVID-19 Diagnostic Test
The FDA has reissued the emergency use authorization (EUA) for the LabCorp COVID-19 RT-PCR Test to include two new indications for use: testing for people who do not have COVID-19 symptoms or who have no reason to suspect COVID-19 infection, and to allow pooled sample testing. The LabCorp test remains prescription-only and is authorized for human specimen collection either at home using the Pixel by LabCorp or other home sample collection kits authorized for use with LabCorp’s test, or by a health care provider. However, only health care provider-collected samples may be pooled at this time. More Information.
Safety Alert: Hand Sanitizers
The FDA continues to warn consumers and health care professionals to not use certain alcohol-based hand sanitizers due to the dangerous presence of methanol. Methanol can be toxic when absorbed through the skin and life-threatening when ingested. The agency has also taken additional action to help prevent certain hand sanitizers from entering the United States by placing them on an import alert. The FDA’s do-not-use list of dangerous hand sanitizer products is updated regularly. More Information.