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.
Category: Compliance
Compliance
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Compliance
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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.
Compliance
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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.
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.
Read MoreCMS Issues Change Request for HCPCS Codes
CMS has issued a change request to inform Medicare administrative contractors about new HCPCS codes that are subject to and excluded from CLIA edits.
Read MoreHHS Finalizes Historic Rules to Provide Patients More Control of Their Health Data
Final rules require access to health information, spur innovation, and aim to end information blocking.
Read MoreFDA and FTC Warn Seven Companies Selling Fraudulent Products that Claim to Treat or Prevent COVID-19
FDA and the Federal Trade Commission (FTC) issued warning letters to seven companies for selling fraudulent COVID-19 products.
Read MoreFDA Issues Clinical Laboratory Improvement Amendments-Related Final Guidances
FDA has recently issued two guidance documents for developers of in vitro diagnostics.
Read MoreIllumina Files Patent Infringement Suits against BGI in Sweden and the United Kingdom
Illumina has filed two additional patent infringement suits relating to BGI’s sequencing products. Related patent suits are pending in Denmark, Germany, Switzerland, Turkey and the United States.
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MSBiosuite Bioinformatics Platform Tackles NGS Data Analytics
The Cloud-based solution automates the analysis of next-generation sequencing data for liquid biopsy and FFPE workflows.
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