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FDA to Spacelabs: Get Consultant to Audit on CAPA, MDR Issues
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FDA Not Specifying Data Capture Tech for UDI, FAQ Guidance Says
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Medtronic Boasts Stocked Pipeline, Defends Merger on Earnings Call
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FDA: Keep Track of Sex Differences Throughout the Device Trial Process
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FDA Denies Waxler Lasik Petition: Former FDAer Still Seeking Recall
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Study Finds Implanted Cardiac Devices Equally Effective Across Racial Groups
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FDA Action Plan Will Enhance Demographic Data in Trials
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CMS to Hold Back Some Data in Public Launch of Sunshine Database
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U.S. Treasury: Device Tax Payments Missed Target by More Than $250M
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FDA Drops Controversial Presubmissions IDE Process in Final Clinical Trials Guidance
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