Distribution of diagnostics and devices without premarket approval has featured prominently on the FDA’s enforcement priority list this year. The agency has issued seven warning letters related to … [Read more...]
FDA Resounds the Alarm on Biotin Test Interference
January 2, 2020
In early November 2019, the FDA undated a previous safety communication about the potential of biotin to significantly interfere with diagnostic tests. The update reiterates the warning to lab … [Read more...]
NEW PRODUCT DEVELOPMENT
New Product Development: FDA Issues Final Guidance on IVD Oncology Trials
November 15, 2019
On Oct. 10, 2019, the FDA finalized guidance on an optional streamlined submission process to determine whether use of an investigational in vitro diagnostic (IVD) in an oncology clinical trial is … [Read more...]
FDA
LDTs: FDA Gets Tough with Non-Approved PGx Testing Claims
September 16, 2019
The FDA has apparently set its enforcement sights on Laboratory Developed Tests (LDTs) that claim to predict patients' responses to medications. It began in 2018, when the FDA warned consumers and … [Read more...]
FDA
Inside Washington: What’s Going on with Regulation of LDTs?
September 9, 2019
Although things appear to be quiet, progress is actually being made in the quest to create workable regulation of Laboratory Developed Tests (LDTs) developments. Here's a rundown of the latest … [Read more...]
FDA
New FDA Guidance Tells IVD Makers How to Test for Biotin Interference
July 16, 2019
On June 13, the FDA issued a draft guidance explaining how makers of in vitro diagnostic devices (IVDs) should perform biotin interference testing and communicate testing results to labs, clinicians … [Read more...]
NEWS
FDA Watch: Agency Okays Marketing of Zika Test for First Time
June 24, 2019
Over the past several years, the FDA has issued Emergency Use Authorization (EUA) for over a dozen different tests for Zika. But on May 23, 2019, the FDA did something it had never done before: It … [Read more...]
FDA
Case of the Month: FDA Issues Warning Letter for Unapproved Changes to Approved Assay
May 28, 2019
As a rule of thumb, FDA approvals are a snapshot applicable only to the product as it exists at the time of review and approval. So, when the product undergoes significant changes, it often triggers … [Read more...]
COMPLIANCE
Compliance Alert: FDA Warning Letter to Inova Genomics Laboratory
April 15, 2019
By Danielle Sloane bio and Elaine Naughton bio Despite it being a continual topic of discussion, the Food and Drug Administration ("FDA") enforcement in the realm of laboratory developed tests … [Read more...]
NEWS
Gottlieb Resigns as FDA Chief: Lab Industry Loses a Good Frenemy
March 25, 2019
Scott Gottlieb, M.D., is resigning as FDA commissioner, the position he's held since 2017. But while his reign lasted just two years, Gottlieb has been a longtime friend and foe of the lab industry … [Read more...]
