FDA Watch

2020 Was a Record Year for New Medical Device Approvals—And Not Just for COVID-19

They say that necessity is the mother of invention. But, historically, invention has never been the problem for creators of novel medical devices; the real challenge for these inventors has been more … [Read more...]

LDTs

FDA Clears Neutralizing Antibodies Detection Test for COVID-19

Innovative new COVID-19 tests continue to emerge from the pipeline. One of the novel diagnostic products that has flown slightly under the radar is the cPass SARS-CoV-2 Neutralization Antibody … [Read more...]

FDA Watch

FDA Watch: Molecular Tests May Miss New SARS-CoV-2 Strains, Agency Warns

Like many viruses, the SARS-CoV-2 is a shape-shifter. And that may make it harder to detect. With this in mind, the U.S. Food and Drug Administration (FDA) is warning clinical laboratories and health … [Read more...]

FDA

Neutralizing Antibodies Detection Test for COVID-19 Gets the FDA Greenlight

Innovative new COVID-19 tests continue to emerge from the pipeline. One of the products that has flown slightly under the radar is the cPass SARS-CoV-2 Neutralization Antibody Detection Kit from … [Read more...]

FDA Watch

Agency Authorizes First OTC All-in-One At-Home COVID-19 Testing Kit

Since the pandemic began, the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for more than 225 COVID-19 diagnostic tests. Among these, 25 have been cleared for … [Read more...]

FDA Watch

Agency Authorizes First Fully At-Home COVID-19 Testing Kit

With COVID-19 cases surging, the U.S. Food and Drug Administration (FDA) made history on Nov. 17 by granting Emergency Use Authorization (EUA) to an all-in-one COVID-19 diagnostic that allows people … [Read more...]

The Business of Testing

HHS Orders FDA to Resume EUA Review of Laboratory Developed Tests for COVID-19

Oh no you don’t! A month after the U.S. Food and Drug Administration (FDA) announced its decision to discontinue review of applications for Emergency Use Authorization (EUA) submitted by test makers … [Read more...]

FDA Watch

Agency Temporarily Allows Modifications of Influenza and RSV Tests Without Premarket Notification

On Oct. 13, the U.S. Food and Drug Administration issued new guidance on molecular diagnostic tests for influenza and respiratory syncytial virus (RSV). The upshot of the guidance is to temporarily … [Read more...]

LDTs

FDA Pulls the Plug on EUA Review of Laboratory Developed Tests for COVID-19

On Oct. 9, the U.S. Food and Drug Administration (FDA) dropped a bombshell by announcing that it would no longer review applications for Emergency Use Authorization (EUA) submitted by test makers for … [Read more...]

FDA Watch

Agency to Provide Emergency Clearance for Multi-Analyte Respiratory Panels

We are now seven months into the COVID-19 public health emergency and flu season is rapidly approaching. Several diagnostics test producers have responded to this convergence by creating new … [Read more...]


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