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
Final Rule Clarifies Liability for Off-Label Uses and Lab’s Right to Create LDTs
September 13, 2021
FDA Watch
Agency Imposes 2.5 Percent Increase in 2022 Premarket Application User Fees
September 6, 2021
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
August 23, 2021
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
August 17, 2021
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
August 5, 2021
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
July 20, 2021
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
July 11, 2021
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
July 1, 2021
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
June 14, 2021
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
June 8, 2021
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...]
