Spurred by the pandemic, the FDA authorized more novel medical devices in 2020 than it ever has in any single year. I know what you’re thinking. “Of course, new medical device approvals were off the … [Read more...]
FDA Watch
Ortho Clinical Diagnostics Gets Green Light for Mass SARS-CoV-2 Antigen Test
February 19, 2021
Almost from the moment the pandemic began, high throughput testing for use in mass screening has occupied a high place on the FDA’s coronavirus diagnostics priority list. On Jan. 12, 2021, Ortho … [Read more...]
FDA Watch
Agency Greenlights First Over-the-Counter, At-Home COVID-19 Testing Kit
January 10, 2021
Nearly 250 COVID-19 diagnostic tests have gotten Emergency Use Authorization (EUA) from the FDA since the pandemic started. Almost all of them have been prescription products. In addition, 25 test … [Read more...]
FDA Watch
Lucira Health Secures First EUA for Fully At-Home COVID-19 Testing Kit
December 2, 2020
Although the FDA has previously authorized COVID-19 diagnostic tests for at-home sample collection, it had never before granted Emergency Use Authorization (EUA) for an all-in-one diagnostic kit that … [Read more...]
FDA Watch
Agency Temporarily Allows Modifications of Influenza and RSV Tests Without Premarket Notification
November 5, 2020
On Oct. 13, the FDA issued new guidance on molecular diagnostic tests for influenza and respiratory syncytial virus (RSV). The upshot of the guidance is to temporarily allow makers of flu and RSV … [Read more...]
FDA Watch
Respiratory Panel Tests Flow from EUA Pipeline Ahead of Flu Season
October 8, 2020
The robust COVID-19 testing EUA pipeline has opened up a new opportunity for companies that produce multi-analyte panels capable of detecting not only the SARS-CoV-2 virus but other respiratory viral … [Read more...]
FDA Watch
Saliva COVID-19 Tests Offer Way Around Nasopharyngeal Swab Shortage Bottlenecks
September 4, 2020
Shortages of the nasopharyngeal swabs used to collect respiratory samples for reverse transcription polymerase chain reaction (RT-PCR) tests has impeded the efforts of laboratories to meet the … [Read more...]
Emerging Tests
FDA Offers New Guidance on Validating SARS-CoV-2 Tests in “Non-Laboratory” Settings
August 20, 2020
SARS-CoV-2 testing in homes, workplaces, airports, schools, sports venues and other non-traditional diagnostic settings is likely to play an increasingly important role in the months ahead. The FDA … [Read more...]
FDA Watch
Agency Green Lights First SARS-CoV-2 Tests for Sample Pooling
August 20, 2020
Revising an Emergency Use Authorization (EUA) to permit a new clinical use is usually pretty routine stuff. But the expanded EUA the FDA announced on July 18 was both unprecedented and significant … [Read more...]
FDA Watch
Agency Sounds the Warning on False-Positives from Becton Dickinson SARS-CoV-2 Reagents
August 12, 2020
On July 6, the U.S. Food and Drug Administration (FDA) issued a warning letter alerting clinical laboratory staff and providers of the increased risk of false-positive results from Becton Dickinson … [Read more...]
