FDA Watch

HHS Restores Agency’s Premarket Review of LDTs

For over a year, makers of laboratory developed tests (LDTs) have been free of the yoke of US Food and Drug Administration (FDA) premarket review requirements. But on November, the Department of … [Read more...]

FDA Watch

Agency Regains Its Authority to Regulate Laboratory Developed Tests (LDTs)

In a surprising reversal of policy that had already been reversed in recent months, the US Department of Health and Human Services (HHS) announced that the US Food and Drug Administration (FDA) will … [Read more...]

FDA Watch

Agency Regains Its Authority to Regulate Laboratory Developed Tests (LDTs)

In a surprising reversal of policy that had already been reversed in recent months, the US Department of Health and Human Services (HHS) announced that the US Food and Drug Administration (FDA) will … [Read more...]

EUA

FDA Imposes New Limits on COVID-19 Tests with Access to EUA Pathway

On Nov. 15, the US Department of Health and Human Services (HHS) stunned the laboratory industry by announcing that the US Food and Drug Administration (FDA) would once more require new COVID-19 … [Read more...]

NEW TESTS

CMS Repeals Rule Providing Expedited Medicare Coverage for MCIT “Breakthrough” Devices

It’s official. On Nov. 12, the US Centers for Medicare and Medicaid Services (CMS) announced that it was repealing a Trump administration final rule that, effective Dec. 15, 2021, would have expedited … [Read more...]

FDA Watch

Management Expert Report Cites Weaknesses in Agency’s EUA Processes

From almost the moment the COVID-19 public health emergency was declared, the US Food and Drug Administration (FDA) has come under fire for not making better use of its emergency use authorization … [Read more...]

FDA Watch

Agency Finalizes Rule on Off-Label Uses Liability and Rights of Laboratories to Create LDTs

On Aug. 2, 2021, the U.S. Food and Drug Administration (FDA) published the long-awaited final rule updating its “intended use” regulations for medical devices and drugs. Here is a quick briefing of … [Read more...]

Reimbursement

Biden Pulls Plug on Automatic Medicare Coverage for MCIT “Breakthrough” Devices

In a reminder of why politics and presidential elections matter so much, the Biden administration announced that it’s scrapping a Trump regulation that would have automatically provided initial … [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

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...]


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