Troubles continue for one of the country’s leading producers of rapid COVID-19 diagnostics. In September, the US Food and Drug Administration posted an alert to its website warning testing labs of the … [Read more...]
FDA
FDA Targets High Throughput COVID-19 Tests for Recall Due to Risks of False Positives
October 19, 2021
FDA
FDA Hikes Premarket Application User Fees by 2.5 Percent
September 23, 2021
Applying for FDA premarket review of medical devices will be more expensive next year. On August 2, the agency announced that it’s raising premarket approval (PMA) user fees by 2.5 percent in FY … [Read more...]
FDA
FDA Hikes Premarket Application User Fees by 2.5 Percent
August 26, 2021
Applying for FDA premarket review of medical devices will be more expensive next year. On Aug. 2, the agency announced that it’s raising premarket approval (PMA) user fees by 2.5 percent in FY … [Read more...]
LDTs
VALID and VITAL Are Back in Play—and This Time One of Them Might Actually Pass
July 20, 2021
The COVID-19 pandemic exposed the truth of something the lab industry has known and publicly stated repeatedly for over a decade: The FDA is ill-equipped to regulate Laboratory Developed Tests (LDTs) … [Read more...]
FDA
FDA Clears the Way for Over-the-Counter Sale of COVID-19 Home Test Kits
February 19, 2021
Since the pandemic began, the FDA has granted Emergency Use Authorization (EUA) for more than 250 COVID-19 diagnostic tests. Among these, nearly 30 have received clearance for at-home collection; a … [Read more...]
FDA
FDA Sounds Alarm on Potential Impact of Genetic Mutation on SARS-CoV-2 Molecular Test Accuracy
January 30, 2021
As if COVID-19 testing wasn’t challenging enough, the emergence of new variants has made the SARS-CoV-2 virus a moving target. With this in mind, the FDA is warning clinical labs and health care … [Read more...]
FDA
FDA Clears the Way for Over-the-Counter Sale of COVID-19 Home Test Kits
January 30, 2021
Since the pandemic began, the FDA has granted Emergency Use Authorization (EUA) for more than 250 COVID-19 diagnostic tests. Among these, 25 have received clearance for at-home collection; a couple … [Read more...]
FOCUS ON
What a Biden Administration Might Portend for Regulation of Laboratory Developed Tests
November 17, 2020
The roller coaster that has become FDA regulation of laboratory developed tests (LDTs) is about to get even more topsy-turvy now that Joseph Biden has been elected President of the United States. … [Read more...]
HHS Announcement
The FDA Drops a Bombshell: No More EUA Review of COVID-19 LDTs
October 19, 2020
Perhaps one of the only positive things to come out of the COVID-19 crisis has been its exposure of the flaws in the FDA’s ham-handed system (if it can be called a system) of premarket regulation of … [Read more...]
EUA
FDA to Issue Emergency Use Authorization for Multi-Analyte Respiratory Panels During the Pandemic
September 17, 2020
The convergence of flu season with the global COVID-19 pandemic will create the need for new multi-analyte respiratory panel tests that are capable of not only detection of but also differentiation … [Read more...]
