USA – CDRH officials dissect early-pandemic test guidance missteps

A guidance permitting use of certain COVID-19 antibody tests had downstream negative consequences that the US Food and Drug Administration (FDA) did not envision when the document was issued nearly a year ago, including inappropriate use of the tests and an influx of tests based on falsified data or marketed with false claims.

In a New England Journal of Medicine editorial, two senior FDA officials laid out the agency’s experience with COVID-19 antibody tests, highlighting missteps and sharing lessons learned to improve practice going forward.

The director of FDA’s Center for Devices and Radiological Health (CDRH), Jeffrey Shuren, MD, JD, and Timothy Stenzel, MD, PhD, the director of CDRH’s Office of In Vitro Diagnostics and Radiological Health, observed that a host of factors surrounding the public health emergency of the COVID-19 pandemic meant that the agency’s previous experiences with regulating in vitro diagnostics had limited applicability…