After a couple of years of dormancy, the FDA laboratory developed test (LDT) enforcement volcano stirred on April 4, when the agency issued a warning letter to Inova Genomics Laboratory (Inova) for … [Read more...]
INDUSTRY BUZZ
FDA Watch: New Warning Letter May Signal Resurgence of LDT Enforcement Activity
April 29, 2019
INDUSTRY BUZZ
FDA Watch: Gottlieb Resignation Costs Lab Industry a Valuable Frenemy
March 27, 2019
Scott Gottlieb, M.D., is resigning as FDA commissioner, the position he's held since 2017. Although his reign lasted just two years, Gottlieb has been a longtime friend and foe of the lab industry … [Read more...]
INDUSTRY BUZZ
FDA Watch: Agency Finalizes New Medical Device Marketing Pathway & Okays Direct Lab Reporting of PGx Test Results
February 25, 2019
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...]
INDUSTRY BUZZ
FDA Watch: Agency Floats Plan to Simplify 510(k) Premarket Review
January 28, 2019
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...]
INDUSTRY BUZZ
FDA Watch: First NGS Residual Cancer Detection Test Wins Approval
December 31, 2018
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
November 19, 2018
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
October 2, 2018
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...]
NEW PRODUCTS
FDA Watch: Lab Industry Objects to Agency’s New LDT Proposal
September 10, 2018
On Aug. 3, the Food and Drug Administration heated the long simmering controversy over FDA regulation of laboratory developed tests (LDTs) to full boil by submitting a new proposal to Congress, … [Read more...]
INDUSTRY BUZZ
FDA Watch: Agency Confirms that LOINC Coding of IVD Tests Is Voluntary
August 1, 2018
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
July 3, 2018
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...]
