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...]

Reimbursement

New LCD Expanding Medicare Coverage for Circulating Tumor Cells Tests Is a Win for Biocept

Biocept announced that it has received expanded Medicare coverage for use of its Target Selector assay to identify HER-2 positive circulating tumor cells under a final CMS local coverage determination … [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

Congress Retables VALID and VITAL Legislation to Regulate LDTs

The U.S. Food and Drug Administration’s response to the COVID-19 public health emergency has infused the longstanding efforts to overhaul the agency’s system of regulating Laboratory Developed Tests … [Read more...]

LDTs

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...]

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

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...]

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...]


(-00000g2)