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...]
LEGISLATION
From DAIA to the VALID ACT: The Latest Chapter in FDA Diagnostic Test Oversight Reform
January 28, 2019
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...]
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...]
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...]
