LDTs: FDA Announces New Approach to 510(k) Approvals

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January 8, 2019

FOCUS ON
LDTs: FDA Announces New Approach to 510(k) Approvals
From - National Intelligence Report
Last month, the FDA floated a plan to overhaul and modernize the 510(k) premarket review pathway allowing for faster, safer approval of medical devices, including…
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INDUSTRY BUZZ
Earnings Report: Top Payers Announce Q3 Earnings
From - Laboratory Industry Report
The country's five largest commercial payers posted strong results for the third quarter of fiscal year 2018…
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GENETIC TESTING
Most Oncologists Report Using Sequencing-Based Panels In Practice
From - Diagnostic Testing & Emerging Technologies
The majority of U.S. oncologists report using next-generation sequencing-based (NGS-based) tests to guide patient care, according to a study published…
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LEGISLATION
Compliance Alert: New Private-Pay Opioid Law Puts All Drug Addiction & Rehab Labs at Risk of Federal Prosecution
From - Lab Compliance Advisor
Recent federal legislation addressing the opioid crisis may have unintended consequences on the lab industry. The idea was to allow the feds to prosecute a certain kind of…
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