FDA Watch

Final Rule Clarifies Liability for Off-Label Uses and Lab’s Right to Create LDTs

On August 2, 2021, the FDA published the long-awaited final rule updating its “intended use” regulations for medical devices and drugs. Here’s a quick briefing of the new rules, which take effect on … [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 Hikes Premarket Application User Fees by 2.5 Percent

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...]

FDA Watch

FDA Watch: VALID and VITAL Bills for LDTs Regulation Are Back in Play

Reform of FDA Laboratory Developed Tests (LDTs) regulation is back on the agenda and this time it may result in actual legislation. Fired by the agency’s ineffectiveness in bringing new SARS-CoV-2 … [Read more...]


VALID and VITAL Are Back in Play—and This Time One of Them Might Actually Pass

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...]


Congress Reintroduces Rival VALID and VITAL Acts to Regulate New Lab Tests

VALID and VITAL are familiar acronyms to those of you who’ve been following the long-running effort to impose order on the FDA’s regulation of Laboratory Developed Tests (LDTs). Now both of those … [Read more...]

Increasing Revenue

Manufacturers Wait Anxiously for CMS Decision on Automatic Medicare Coverage of MCIT Breakthrough Devices

Makers of innovative medical devices makers will remain on pins and needles after CMS’s decision to once more delay a final rule that would automatically provide initial Medicare coverage for new … [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 Okays COVID-19 Blood Spot Self-Collection & Molecular Test Pooling

Pandemic pressures continue to produce unprecedented action from the FDA. The current imperative is to clear assays and collection kits for rapid and easy screening, including products that can be … [Read more...]