ABSTRACT

Revocation of EUA200179   [open pdf - 301KB]

From the Introduction: "After consideration of the totality of scientific evidence available to the Agency, including all of your submissions, FDA has determined under section 564(g)(2)(B) that the criteria for issuance of emergency authorization in section 564(c) of the Act are no longer met for the DPP COVID-19 [coronavirus disease 2019] IgM/IgG System. Under section 564(c)(2) an EUA [emergency use authorization] may be issued only if FDA concludes it is reasonable to believe the product may be effective and the known and potential benefits outweigh the known and potential risks. Given the poor device performance observed in multiple evaluations since authorization described above, FDA has concluded it is not reasonable to believe the product may be effective in detecting antibodies against SARS-CoV-2 [severe acute respiratory syndrome coronavirus 2] or that the known and potential benefits of [this] device outweigh its known and potential risks. In addition, based on the same information and the risks to public health from false test results, FDA has concluded under section 564(g)(2)(C) that other circumstances make revocation appropriate to protect the public health or safety."

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Date:
2020-06-16
Series:
Copyright:
Public Domain
Retrieved From:
U.S. Food and Drug Administration: https://www.fda.gov/
Format:
pdf
Media Type:
application/pdf
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