False Positive Recalls Casts Doubt on Rapid COVID Screening Tests at the Worst Possible Time

Late last year, the US Food and Drug Administration (FDA) began issuing emergency use authorization (EUA) for a new breed of COVID-19 tests designed not so much to diagnose but screen for the virus on … [Read more...]


FDA Requires EUA SARS-CoV-2 Test Developers to Account for Viral Mutations

New rules from the U.S. Food and Drug Administration (FDA) require producers of SARS-CoV-2 tests that have received Emergency Use Authorization (EUA) to take additional steps to account for viral … [Read more...]

FDA Watch

Agency Finalizes Rule on Off-Label Uses Liability and Rights of Laboratories to Create LDTs

On Aug. 2, 2021, the U.S. Food and Drug Administration (FDA) published the long-awaited final rule updating its “intended use” regulations for medical devices and drugs. Here is a quick briefing of … [Read more...]

FDA Watch

Agency Imposes 2.5 Percent Increase in 2022 Premarket Application User Fees

Although the FY 2022 fees increase is less than half of last year’s increase, applying to the US Food and Drug Administration (FDA) for premarket review of medical devices will still be more expensive … [Read more...]

Testing Trends

FDA Regulation of COVID-19 Testing Enters a New Phase

The public health emergency (PHE) is still in effect but the honeymoon has ended. The leniency that the U.S. Food and Drug Administration (FDA) has displayed toward COVID-19 tests and test makers … [Read more...]

FDA Watch

First Ever Approval of COVID-19 Blood Spot Self-Collection & Molecular Test Pooling

The U.S. Food and Drug Administration (FDA) continues to step outside its traditional comfort zone in response to COVID-19 pandemic pressures. Among the most recent agency firsts is best seen as part … [Read more...]

FDA Watch

Newly Reintroduced VITAL Act Would Strip Agency of LDT Regulatory Authority

When history is written, acceleration of the longstanding effort to eliminate the authority of the U.S. Food and Drug Administration (FDA) to regulate Laboratory Developed Tests (LDTs) may be … [Read more...]

FDA Watch

Agency Streamlines Authorization of COVID-19 Molecular Test Pooling for Screening Programs

Last July, in an effort to meet the desperate need for high throughput COVID-19 testing, the U.S. Food and Drug Administration (FDA) issued the first clearance for use of a previously authorized test … [Read more...]

FDA Watch

First De Novo Clearance Signals that Premarket Pathway Is Open for COVID-19 Tests

Just over a year ago, the U.S. Food and Drug Administration (FDA) granted its first Emergency Use Authorization (EUA) for a coronavirus test. On March 17, 2021, the test review process moved to a new … [Read more...]

Genetic Testing

New Study Supports Use of Liquid Biopsy Technology to Bolster MRI Accuracy in Cancer Treatment

Important new evidence has emerged supporting the capabilities of liquid biopsy to enhance the accuracy of magnetic resonance imaging (MRI) for cancer diagnosis and treatment. That evidence comes from … [Read more...]