FDA Takes Shot Across the Bow with LDT Rulemaking
The FDA has issued proposed LDT rulemaking. Laboratories have an opportunity to make comments before it becomes official.
Category: Compliance
Compliance
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Compliance
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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.
Compliance
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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.
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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New CMS Resource Helps Labs Apply for CLIA Certification
The “Laboratory Quick Start Guide for CLIA Certification” outlines all of the necessary steps laboratories must follow.
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CMS Releases New Tools to Streamline Certification for Labs Testing for COVID-19
CMS’s quick-start guide helps laboratories with the application process for CLIA certification and includes information on the expedited review process.
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CMS Posts New Covid-19 Testing Requirements for Labs, Nursing Homes
A memo recommends that facilities conducting patient lab tests use authorized detection antigens to prevent the spread of covid-19 in nursing homes.
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FDA Posts New Web Page for Covid-19 Testing
The page offers resources such as emergency use authorization templates and FAQs regarding surveillance testing and the testing of asymptomatic individuals.
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CMS Approves COLA for Virtual Laboratory Surveys
The virtual laboratory survey process consists of three parts: documentation, review, and a video conference.
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FDA Posts New Template for Covid-19 Diagnostics for Non-Lab Settings
The template will help developers submit EUA requests for covid-19 diagnostics that can be performed entirely in settings such as homes, offices, or schools.
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FDA Virtual Town Hall for Clinical Labs, Manufacturers
On 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 MoreFDA Updates Templates for Serology Test EUA Requests
The updates clarify FDA’s previous recommendations for demonstrating clinical performance and presenting validation data and provide new recommendations.
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Managing Prior Authorizations with Artificial Intelligence
AI-driven software can help labs expertly navigate the prior authorization landscape.
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FDA Proposes to Reclassify Two Types of Hepatitis C Virus Diagnostic Tests
If the agency’s proposed reclassification is finalized, devices of this type may go through the 510(k) pathway for clearance instead of the premarket approval (PMA) pathway.
Read MoreDigital Pathology Association Commends CMS for Waiving Restrictions on Remote Pathology Diagnoses
The waiver will provide temporary relief from federal regulations requiring pathologists to render primary diagnoses onsite at healthcare facilities.
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