From DAIA to the VALID ACT: The Latest Chapter in FDA Diagnostic Test Oversight Reform

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  Lab and Pathology Insider Logo  
January 29, 2019  
placeholder LEGISLATION
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…
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placeholder INDUSTRY TRENDS
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…
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placeholder INDUSTRY BUZZ
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…
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placeholder CMS
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…
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