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...]
FDA Watch
2020 Was a Record Year for New Medical Device Approvals—And Not Just for COVID-19
February 21, 2021
LDTs
FDA Clears Neutralizing Antibodies Detection Test for COVID-19
February 21, 2021
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
February 11, 2021
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
January 30, 2021
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
January 6, 2021
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
December 2, 2020
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
November 24, 2020
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
November 3, 2020
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
November 2, 2020
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
September 22, 2020
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...]
