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...]
Testing Trends
FDA Regulation of COVID-19 Testing Enters a New Phase
August 26, 2021
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
FDA Hikes Premarket Application User Fees by 2.5 Percent
August 26, 2021
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
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...]
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...]
LDTs
Congress Reintroduces Rival VALID and VITAL Acts to Regulate New Lab Tests
July 1, 2021
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
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...]
FDA Watch
Agency Okays COVID-19 Blood Spot Self-Collection & Molecular Test Pooling
June 14, 2021
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...]
