While FDA oversight over new diagnostic tests is perfectly acceptable, what is objectionable is the agency's continued reliance on a regulatory regime designed not for lab tests but medical devices. … [Read more...]
LEGISLATION
From DAIA to the VALID ACT: The Latest Chapter in FDA Diagnostic Test Oversight Reform
January 28, 2019
NEWS
Government Shutdown: The Impact on the Agencies that Regulate Labs
January 23, 2019
As we go to press, the longest U.S. government shutdown in history drags on with no end in sight. And while it may not affect your lab directly, the shutdown will have an indirect impact to the extent … [Read more...]
FDA
LDTs, FDA-Approved Companion Diagnostics Perform Similarly; Off-Label Use of Companion Diagnostic Kits Common
January 3, 2018
One of the arguments for U.S. Food and Drug Administration oversight over laboratory-developed tests (LDTs) involves the need for greater assurances regarding the quality and consistency of these … [Read more...]
GUIDELINES
FDA Warns About Biotin Interference With Lab Tests
January 3, 2018
In late November the U.S. Food and Drug Administration issued a safety communication warning that the supplement biotin (Vitamin B7) may interfere with laboratory testing results. The warning comes … [Read more...]
LAB SAFETY
CLIA Corner: FDA Moves to Boost CLIA Waiver Transparency
November 30, 2017
The CLIA standards that a lab must meet are based on the complexity of the in vitro diagnostic tests it performs. The FDA's primary role in the CLIA system is to categorize IVDs. Test … [Read more...]
DISTINGUISHED SERVICE
Kellison Award goes to FDA’s Dr. Alberto Gutierrez
October 26, 2017
Dr. Alberto Gutierrez is the 2017 recipient of the Kellison Lab Industry Distinguished Service Award. Dr. Guitierrez retired in August after more than 25 years of public service from his post as … [Read more...]
FDA
Forget 2014: New Discussion Paper Outlines FDA’s Current Thinking on LDT Regulation
January 26, 2017
In December, the U.S. Food and Drug Administration ended two years of anticipation or dread, depending on your point of view, by announcing that it would not finalize the guidance on agency oversight … [Read more...]
FDA
FDA Puts Final LDT Guidance on Ice—Agency Decides to Wait for Trump Administration
November 28, 2016
Whether you dreaded it or craved it, you will not be getting it—at least not any time soon. In the wake of the election, the U.S. Food and Drug Administration (FDA) let it be known that it will not … [Read more...]
FDA
Liquid Biopsies Get FDA Attention
August 15, 2016
In addition to laboratory developed tests and next generation sequencing, could the FDA be looking to impose standards or guidance governing use of liquid biopsies? So-called "liquid … [Read more...]
TECHNOLOGY
Congressional Leaders Query FDA and CMS about Theranos
August 15, 2016
Earlier this summer, ranking members of U.S. House of Representatives Committee on Energy and Commerce requested a briefing from Theranos to inform the committee about Theranos' efforts to comply with … [Read more...]
