FDA Issues Emergency Use Authorization for Hologic and LapCorp COVID-19 Tests
This week the FDA made a major move to increase the availability of diagnostics that can detect the COVID-19 virus during this public health emergency. The agency issued Emergency Use Authorization to Hologic for its Panther Fusion SARS-COV2 Assay and LabCorp for its COVID-19 RT-PCR test.
“Our device center has been in continual contact with the medical device community, in particular diagnostic developers, since January—providing technical assistance to test developers to help facilitate the availability and distribution of tests so that health care professionals can accurately detect the COVID-19 virus,” said FDA Commissioner Stephen M. Hahn, M.D. “Since the beginning of this outbreak, more than 90 test developers have sought FDA guidance with the development and validation of tests they plan to bring through the EUA process. Additionally, more than 40 laboratories have notified us that they are testing or intend to begin testing soon under our new policy for laboratory-developed tests for this emergency. We stand ready to continue to support medical products in the pipeline to fight this virus.”
Related Articles
-
The omicron variant of the coronavirus has made clear that the impact of the pandemic is far from over, particularly for health systems and hospitals. The ongoing need to limit close contact between providers and patients means technology will continue…
-
Effective February 7, the agency will conduct inspections across all commodities, as well as mission-critical foreign and domestic inspections.
-
The draft guidance proposes updates to clarify how the Breakthrough Devices Program may be applicable to certain medical devices that promote health equity, as well as considerations in designating eligible devices that may benefit populations impacted by disparities in health…
-
As of June 1, 2022, the Center for Devices and Radiological Health plans to accept all non-COVID in vitro diagnostic (IVD) pre-submissions.
