On June 13, the FDA issued a draft guidance explaining how makers of in vitro diagnostic devices (IVDs) should perform biotin interference testing and communicate testing results to labs, clinicians …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...]
EMERGING TESTS
FDA Greenlights Assays Using New Test Model for Lyme Disease Diagnosis
August 28, 2019
Lyme disease is on the increase. And so is the number of products cleared for detecting it. In fact, products for detecting tickborne diseases have been reaching the U.S. market at a dramatically … [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...]
TESTING STRATEGY
FDA Issues Warning for ‘Over Reliance’ on Rupture of Membrane Tests
August 28, 2018
Health care providers may be over relying on rupture of membrane (ROM) test results when making critical patient management decisions, according to a U.S. Food and Drug Administration (FDA) warning. … [Read more...]
REGULATORY
FDA Considering Self-Collection Sample Regulation
November 15, 2017
The U.S. Food and Drug Administration (FDA) may be considering selfcollection of samples for cervical cancer screening. The agency is seeking guidance on the evaluation of cervical sample … [Read more...]
REGULATORY
FDA Medical Device User Fees Rise as Part of Reauthorization
November 15, 2017
On Oct. 1, the new 2018 U.S. Food and Drug Administration (FDA) user fees go into effect. Diagnostics manufacturers will notice increased medical device user fees, including a doubling of 510(k) … [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
FDA Reports Progress in Advancing Regulatory Science for Diagnostics
July 17, 2017
The U.S. Food and Drug Administration (FDA) recently unveiled its FY 2015-2016: Regulatory Science Progress Report. The report, the second of its kind under the Food and Drug Administration Safety and … [Read more...]
FUNDING
FDA Speeding Approval Process, Continued User Fees Needed
June 26, 2017
The U.S. Food and Drug Administration (FDA) is plagued with chronic understaffing, scrutiny over the length of time for approvals, and an expanding workload, while also facing potential budget cuts … [Read more...]
EMERGING TESTS
Testing Recommendations Expand as Zika Season Approaches
June 14, 2017
As warm weather sets in across the southern portion of the United States, public health officials are planning for the 2017 Zika season. This mosquito year experts have a better knowledge about the … [Read more...]
