ADLM Says FDA’s LDT Rule Will Hinder Patient Care for the UnderservedÂ
The FDA’s new LDT rule could severely limit access to vital diagnostics, particularly in rural and marginalized communities, ADLM says.
Category: Compliance
Compliance
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Compliance
Latest
CMS and CDC Issue Final Rulemaking Updating CLIA Fees
CMS and the CDC issued Final Rulemaking [CMS-3326-F] to update the CLIA fees and clarify the CLIA fee regulations.
Compliance
Latest
FDA Updates COVID-19 Test Policy
The FDA has updated its COVID-19 test policy to ensure continued access to tests, transitioning traditional premarket review pathways.
CAP Files Amicus Brief in Support of No Surprises Act Lawsuit
The College of American Pathologists warns the No Surprises Act will further drive more physicians out of their patients’ health plan networks.
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Accelerator Facility Launched for Clinical Lab Tests
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.
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FDA Response to COVID Gives Insights for Regulatory Future of LDTs
Certain temporary deviations in FDA policy in response to the COVID-19 pandemic may offer a blueprint for regulatory oversight of LDTs.
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FDA Warns of Potential for False Positives with Roche Cobas SARS-CoV-2 and Influenza Test
Roche Molecular Systems’ cobas SARS-CoV-2 and Influenza A/B Nucleic Acid Test is for use on the cobas Liat System. The false positive results may be related to two issues observed by Roche.
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Helmer i.C3 Download Functionality Supports Clinical Laboratory Compliance
The i.C3 monitors the temperature inside a laboratory refrigerator or freezer and activates alarms if the temperature rises or falls outside of the acceptable range.
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COLA Launches Toolkit for Waived Laboratories
COLA’s Waived Testing Toolkit provides guidance and tools to help staff achieve and maintain waived testing excellence, including guidance on covid-19 reporting.
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FDA Issues New Policy for Evaluating the Impact of Viral Mutations on Covid-19 Tests
The new guidances for medical product developers, specifically covering vaccines, diagnostics, and therapeutic products, address the emergence and potential future emergence of variants of SARS-CoV-2, the virus that causes covid-19.
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MedTrainer Introduces LabComply to Simplify Lab Compliance
LabComply manages laboratory safety, administrative and engineering controls, training, documentation, and reporting as part of MedTrainer’s all-in-one healthcare compliance solution.
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FDA Issues Alert to Clinical Laboratory Staff Regarding SARS-CoV-2 Viral Mutation
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.
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Webinar: Solving Confusion with Regulations, QC Design, and Troubleshooting for SARS CoV-2 Assays
The 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.
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FDA Updates Serology Templates for Covid-19 Test Developers
The two new templates offer recommendations on what to include in emergency use authorization requests for serology tests.
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From the Commissioner: FDA’s Ongoing Commitment to Transparency for Covid-19 EUAs
I 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.
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FDA Updates FAQs on Testing for Covid-19
The changes make it easier to navigate to questions by topic.
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FDA Issues New Enforcement Policy for Modifications to FDA-Cleared Molecular Influenza and RSV Tests
The 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.
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FDA Virtual Town Halls for Labs, Manufacturers of Covid-19 Diagnostics
Today, 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.
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