FDA Watch

Agency Tells EUA SARS-CoV-2 Test Makers to Account for Viral Mutations

On Sept. 23, FDA issued a letter requiring producers of SARS-CoV-2 tests with Emergency Use Authorization (EUA) to take additional steps to account for viral variants. The new Conditions of … [Read more...]

FDA Watch

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

On Aug. 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 took effect on … [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...]

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...]

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

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...]

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

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...]

FDA Watch

Agency Opens Premarket Pathway for Post-Emergency COVID-19 Test Marketing

The public health emergency that began last February will eventually end. But the demand for COVID-19 tests will not. The transition from the emergency to post-emergency test market unofficially began … [Read more...]

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...]


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