Devices

FDA Allows Broader Lab Testing as Virus Spreads

As the coronavirus outbreak grows in the U.S., including two deaths over the weekend related to the illness, FDA has announced a new policy to permit certain laboratories to use tests they develop and validate to improve the testing capacity in the U.S. Earlier test kits developed by CDC for use in U.S. testing have been fraught with manufacturing problems, which likely led to delayed testing and further virus spread, according to an Axios report.

FDA Commissioner Stephen Hahn said in a statement to Axios that government agencies have worked together to resolve the problems with CDC-supplied coronavirus tests. “Upon learning about the test issue from CDC, FDA worked with CDC to determine that problems with certain test components were due to a manufacturing issue,” he said. “FDA has confidence in the design and current manufacturing of the test that already have and are continuing to be distributed. These tests have passed extensive quality control procedures and will provide the high-level of diagnostic accuracy we need during this coronavirus outbreak.”

The new FDA policy will permit certain laboratories to use validated diagnostics before the agency has completed the review of their Emergency Use Authorization (EUA) requests. “The FDA can issue an EUA to permit the use, based on scientific data, of certain medical products that may be effective in diagnosing, treating or preventing a disease or condition when there is a determination, by the Secretary of Health and Human Services (HHS), that there is a public health emergency or a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens, and a declaration that circumstances exist justifying the medical products’ emergency use,” an FDA release says.

FDA has issued an “immediately in effect guidance” that describes the circumstances where it does not intend to object to the use of these tests for clinical testing while the laboratories are pursuing an EUA. “Importantly, this policy only applies to laboratories that are certified to perform high-complexity testing consistent with requirements under Clinical Laboratory Improvement Amendments,” the agency says.

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome