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.
Category: Compliance
Compliance
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Compliance
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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 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.
Digital 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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Inside Track: Expanding Consumer Genomic Testing
AMP President Victoria M. Pratt, PhD, discusses the association’s updated position statement on consumer genomic testing.
Read MorePlanning for PAMA
Now is the time to make sure that hospital executives are fully educated about details of the Protecting Access to Medicare Act of 2014.
Read MoreData Collection under PAMA
Laboratories that meet CMS criteria must collect their private payor data for the first half of 2019, and report it to CMS no later than March 31, 2020.
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Getting Ahead of PAMA
The federal law comes with significant cuts to Medicare testing fees, but labs that take steps now will be better able to meet the challenge.
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CMS Renews Deeming Authority for COLA
The renewal applies to specialties that include clinical chemistry, diagnostic immunology, hematology, immunohematology, and microbiology.
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FDA Proposes 510(k) Exemption for Flow Cytometry Instruments
The agency’s exemption would apply only to cytometry instruments used for counting or characterizing cells.
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CDC, CMS, and FDA Create Tri-Agency Taskforce for Emergency Diagnostics
The emergency diagnostics taskforce will help to prepare the agencies to respond during public health emergencies.
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Xifin Enters Precision Medicine Informatics Market
VisualStrata is a precision medicine informatics platform that uniquely integrates diagnostic, clinical, and financial data to support value-based care initiatives.
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