Labs Express Concern about Testing Access if FDA Regulates LDTs
Nearly 85% of respondents to an ARUP Labs survey on the impact of the FDA's proposed rule to regulate LDTs believe it will hurt their labs.
Nearly 85% of respondents to an ARUP Labs survey on the impact of the FDA's proposed rule to regulate LDTs believe it will hurt their labs.
The Centers for Medicare & Medicaid Services issued a proposed rule that would update the CLIA 1988 fee regulations.
To help diagnostics start-ups from around the world more rapidly enter the U.S. market, 20/20 GeneSystems is giving access to a CLIA laboratory.
The FDA is monitoring the potential impact of viral mutations, including an emerging variant from the United Kingdom known as the B.1.1.7 variant, on authorized SARS-CoV-2 molecular tests.
Read MoreThe webinar, sponsored by Technopath, will cover quality control regulations, setting the proper QC strategy/design, and troubleshooting SARs CoV-2 and other semi-qualitative tests in the laboratory.
Read MoreThe two new templates offer recommendations on what to include in emergency use authorization requests for serology tests.
Read MoreI want to take a moment to reaffirm FDA’s commitment to transparency around the EUA process and share some updates on our plan to provide more information about FDA’s decisions to issue, revise or revoke EUAs for drugs and biological products, including vaccines.
Read MoreThe changes make it easier to navigate to questions by topic.
Read MoreThe FDA has issued and immediately implemented a new guidance: Enforcement Policy for Modifications to FDA-Cleared Molecular Influenza and RSV Tests During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.
Read MoreToday, the FDA will host a virtual Town Hall for clinical laboratories and commercial manufacturers that are developing or have developed diagnostic tests for SARS-CoV-2.
Read MoreThe “Laboratory Quick Start Guide for CLIA Certification” outlines all of the necessary steps laboratories must follow.
Read MoreCMS’s quick-start guide helps laboratories with the application process for CLIA certification and includes information on the expedited review process.
Read MoreA memo recommends that facilities conducting patient lab tests use authorized detection antigens to prevent the spread of covid-19 in nursing homes.
Read MoreThe page offers resources such as emergency use authorization templates and FAQs regarding surveillance testing and the testing of asymptomatic individuals.
Read MoreThe virtual laboratory survey process consists of three parts: documentation, review, and a video conference.
Read MoreThe template will help developers submit EUA requests for covid-19 diagnostics that can be performed entirely in settings such as homes, offices, or schools.
Read MoreOn July 29, the FDA will host a virtual Town Hall for clinical labs and commercial manufacturers involved in developing diagnostic tests for SARS-CoV-2.
Read MoreThe updates clarify FDA’s previous recommendations for demonstrating clinical performance and presenting validation data and provide new recommendations.
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