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Compliance Perspectives: A 10-Step Compliance Strategy for OSHA Recordkeeping Rules
From - Lab Compliance Advisor
January is the season when employers must compile their OSHA logs for the previous year. The good news is that many labs are…
New Study Finds Lab Automation Market Poised for Continued Growth, Focus on Genomics Solutions
From - National Intelligence Report
The lab automation market is expected to reach $5.20 billion by 2022 from an estimated $4.06 billion in 2017, at a CAGR rate of…
From DAIA to the VALID ACT: The Latest Chapter in FDA Diagnostic Test Oversight Reform
From - Lab Compliance Advisor
While FDA oversight over new diagnostic tests is perfectly acceptable, what is objectionable is the…
Diagnostics Sector Saw Increased Investment, Exits in 2018
From - Diagnostic Testing & Emerging Technologies
Life science and health care companies had a banner year in 2018, with a record-breaking year for venture capital investment…
FDA Watch: Agency Floats Plan to Simplify 510(k) Premarket Review
From - Laboratory Industry 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…
CLIA: CMS Proposes 20% Fee Increase—and Further Increases Could Follow
From - National Intelligence Report
As if Year 2 of PAMA lab fees wasn't enough, CMS dished out another dose of agita to the lab industry: CLIA fees will…