INDUSTRY BUZZ

FDA Watch: Agency Finalizes New Medical Device Marketing Pathway & Okays Direct Lab Reporting of PGx Test Results

On Jan. 22, the FDA issued final guidance establishing a new alternative pathway for getting medical devices to market. Under the "Safety and Performance Based Pathway" (new Pathway), new product … [Read more...]

CLIA

After Nearly 3 Decades, CMS Proposes Updates to Proficiency Testing Rules

When the CLIA (the Clinical Laboratory Improvement Amendments of 1988) proficiency testing (PT) regulations were first implemented in 1992, George H.W. Bush was President, gas cost about $1.05 per … [Read more...]

INDUSTRY BUZZ

FDA Watch: Agency Floats Plan to Simplify 510(k) Premarket Review

Last month, the FDA floated a plan to overhaul and modernize the 510(k) premarket review pathway allowing for faster, safer approval of medical devices, including diagnostics. Here's a quick … [Read more...]

CMS

CLIA: CMS Proposes 20% Fee Increase—and Further Increases Could Follow

As if Year 2 of PAMA lab fees wasn't enough, CMS dished out another dose of agita to the lab industry: CLIA fees will be going up 20%, effective this year. Background For those of you who are new to … [Read more...]

INDUSTRY BUZZ

FDA Watch: First NGS Residual Cancer Detection Test Wins Approval

The FDA broke new ground by allowing marketing of Adaptive Biotechnologies' ClonoSEQ assay, a next generation sequencing (NGS)-based test for minimal residual disease (MRD) in patients with acute … [Read more...]

INDUSTRY BUZZ

FDA Watch: Changes to CBER Email Policy May Affect Your Lab

Heads up to any lab that's subject to oversight by the CBER, i.e., the FDA agency responsible for regulating biological products for human use. The agency changed its email communications policy on … [Read more...]

INDUSTRY BUZZ

FDA Watch: New LDT Proposal Is Much Different from One Negotiated with Industry

The lab industry played an active role in the drafting of the Diagnostic Accuracy and Innovation Act (DAIA), a bill designed to establish a new regulatory regime for laboratory developed tests (LDTs). … [Read more...]

INDUSTRY BUZZ

FDA Watch: Agency Confirms that LOINC Coding of IVD Tests Is Voluntary

On June 15, the FDA issued a new guidance document clarifying the rules for laboratory coding of in vitro diagnostic tests. There are four key takeaways for IVD test makers and labs: 1. No … [Read more...]

INDUSTRY BUZZ

FDA Watch: Agency Offers a Modicum of Relief on DTC Marketing of Genetic Tests

Last November, the FDA raised eyebrows with a notice for public comment proposing to make it easier to bring new genetic health risk (GHR) assessment tests to market. The message to GHR test … [Read more...]

INDUSTRY BUZZ

FDA Watch: Why the New NGS Guidance May Be a Paper Tiger

Last month, the FDA finalized a pair of guidance documents designed to liberalize and speed up approval of new next-generation sequencing (NGS) in vitro diagnostic (IVD) tests and devices. (See LIR, … [Read more...]


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