Useful Links
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…
G2 Blog
Q&A on Lab Waste Management
By Dan Scungio, MT (ASCP), SLS, CQA (ASQ) bio
Understanding the proper separation and disposal of the various waste types generated in the lab setting is an important piece of managing the…
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…
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…
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…
Compliance Perspectives: PAMA Pitfalls & Survival Strategies
From – Lab Compliance Advisor
PAMA’s deep Medicare reimbursement cuts have had a devastating impact on the lab industry. Recent CMS changes in the 2019 Final Rule should…