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Health Canada to Require Labeling With Device Licensing Applications
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Australia to Accept CE Mark for ‘Routine’ Medical Devices
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CMS Proposes Limited Coverage of Prolaris Prostate Cancer Test
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FDA Grants Class II Status to IVDs for Mycobacterium TB Complex
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Participants in Single-Audit Pilot Unlikely to See Warning Letters
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Industry: 510(k) Guidance Should Not Usher in New Data Requirements
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Devicemakers Call for Narrower Scope in Surgical Mesh Reclassification
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IMDRF Finalizes Device, IVD Regulatory Submission TOCs
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ProTech Warned Over CAPAs, Procedures, Modifications
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FDA Pilot Aims to Improve Use of Device Development Tools
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New Technology Could Increase Supply of Lungs for Transplant
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Judge Won’t Exclude Some Emails in West Virginia Ethicon Mesh Case
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