AMP Celebrates Decision to Vacate FDA Rule on LDT Regs
A federal court ruled in favor of AMP, striking down the FDA’s attempt to regulate laboratory-developed tests (LDTs) as medical devices.
Category: Compliance
Compliance
Latest
Compliance
Latest
FDA Announces Final Rule on LDT Regulation
The U.S. FDA finalized a rule regarding its oversight of LDTs to make explicit that IVDs are considered devices under the FD&C Act.
Compliance
Latest
AACC Statement on Exclusion of VALID Act from Omnibus Bill
AACC issued a statement supporting the U.S. Congress' exclusion of the VALID Act from its 2023 Omnibus Bill.
Medical & Patient Communities Urge Congress to Stop VALID Act
The AACC joins more than 100 other organizations that have expressed concerns about the Senate HELP committee rushing to pass the VALID Act.
Read More
Do We Really Need VALID Act Regulations?
In CLP’s July cover story, we’re examining how the proposed VALID regulations will affect the laboratory industry and society as a whole.
Read More
Fast Facts: Your Guide to the VALID Act
The bipartisan VALID Act would implement a risk-based review system for all diagnostic tests, including LDTs, under the FDA.
Read More
Do Laboratory-Developed Tests Have a Future?
As the bipartisan VALID Act moves closer to a vote, the potential regulation could impact the future of laboratory-developed tests (LDTs).
Read More
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.
Read More
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.
Read More
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.
Read More
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.
Read More
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.
Read More
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.
Read More
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.
Read More
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.
Read More
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.
Read More
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.
Read More
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.
Read More