The FDA broke new ground by clearing a pair of STD screening assays for detecting chlamydia and gonorrhea for use with extragenital specimens, specifically from the throat and rectum. The tests, … [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...]
INDUSTRY BUZZ
FDA Watch: New Warning Letter May Signal Resurgence of LDT Enforcement Activity
April 29, 2019
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...]
NEWS
FDA Extends Deadline to Comment on Proposed 510(k) Pathway Reform
April 22, 2019
April 22, 2019 was supposed to the last day to comment on newly proposed FDA guidance on changing the Section 510(k) premarket review process for new devices and diagnostic tests. But last week, the … [Read more...]
TOP OF THE NEWS
New Federal Taskforce to Speed Implementation of Emergency Use Diagnostics
April 8, 2019
Three federal agencies announced the creation of a new taskforce to provide timely recommendations to laboratories for rapid implementation of in vitro diagnostic (IVD) assays during public health … [Read more...]
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...]
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...]
FDA
FDA Watch: Latest Plan to Simplify 510(k) Premarket Review of New Tests
March 11, 2019
While everybody agrees that the FDA 510(k) premarket review pathway is antiquated and in desperate need of an overhaul. For several years, the FDA, Congress and lab industry have been working together … [Read more...]
NEWS
Medical Marijuana: CBD Doesn’t Get You “High” But May Make You Fail a Drug Test
February 25, 2019
Testing for marijuana isn't as simple as it used to be thanks to the increased use of cannabidiol (CBD) products. Based on oils extracted from hemp plants, CBD contains little to no … [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...]
