CDRH Prioritizes Point of Care Serology Test EUAs

Uncategorized Jun 15, 2020 Washington, D.C.,

By: Jessica Wasserman, Esq.

On June 10th, we participated on a call hosted by the U.S. Food and Drug Administration Center for Devices and Radiological Health (CDRH) to provide updates on CDRH policies and practices of interest to clinical laboratories and commercial manufacturers that are developing or have developed diagnostic and antibody tests for SARS-CoV-2.

CDRH announced that it is now prioritizing Point Of Care antibody/serology test EUA authorizations. This is an important change because POC testing is what is needed for significantly increasing the number of people tested for antibodies and the country moves to return to work and to school.

At present, of the 96 EUAs authorized, only 3 so far have been authorized to be administered at Point of Care; and of these none are for antibody/serology tests. This means that it is not possible to widely distribute serology antibody tests until CDRH begins authorizing for POC.

To assist developers and manufacturers through the EUA authorization process, FDA has issued a number of “templates” to follow to submit a successful authorization request. FDA has not yet published a template for POC, but announced that it will soon do so:

Molecular Diagnostic Template for Manufacturers (Updated May 13, 2020)
Molecular Diagnostic Template for Laboratories (Updated May 13, 2020)
Serology Template for Manufacturers (unchanged from May 4, 2020)
Serology Template for Laboratories (unchanged from May 4, 2020)
Antigen Template for Manufacturers (May 11, 2020)
Home Specimen Collection Molecular Diagnostic Template (May 29, 2020)

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