FDA Watch: CND Life Sciences Wins Breakthrough Device Designation for Skin-Based Neurodegenerative Test
The Syn-One assay can diagnose multiple conditions without needing a lumbar puncture
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Chevron Doctrine’s Dismissal Has Yet to Upend Regulatory Environment
However, clinical laboratories may have more say in future laws and guidance thanks to 2024 decision
FDA Watch: Mass Spectrometry Test Receives First Moderate Complexity Designation
Roche’s vitamin D assay includes internal quality controls that allowed it to obtain the CLIA designation
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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FDA Details Oversight of Medical Applications On Smart Phones and Tablets
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Final FDA Guidance on RUO, IUO Products Raises Compliance Concerns for Labs
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