FDA Watch

Agency Clears Record Number of New Medical Devices in 2020

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

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

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

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

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

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

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

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

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

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...]