FDA Watch: EU’s New IVD Regulations Could Drive More Firms to Seek FDA Approval
Although the timelines have been extended several times, IVDR complexity has created a concerning bottleneck in the approval process
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Special Report: Preparing for Stage 1 of the FDA’s LDTs Final Rule
Considerations for addressing compliance with Stage 1 of the FDA’s lab-developed tests final rule
How the LDT Final Rule’s Exemptions Apply to Oncology Labs
Regulatory expert explores whether any exclusions might benefit cancer laboratories trying to navigate upcoming compliance deadlines
Liquid Biopsies Get FDA Attention
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Congressional Leaders Query FDA and CMS about Theranos
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FDA Guidance Addresses NGS Testing, Espousing Flexibility in Oversight
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FDA’s LDT Oversight Framework Could Impact 60,000+ Tests
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FDA’s 2016 Guidance Plans Include LDTs and Other Diagnostics Topics
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FDA Workshop Addresses Security of Medical Devices
From - G2 Compliance Advisor
The U.S. Food and Drug Administration (FDA) is joining the cadre of government agencies calling attention to the cybersecurity risks of wireless, internet-and network-connected devices and…
FDA and CMS Address LDT Regulation Before Energy and Commerce Committee
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