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Final Guidance on Home-Use Device Design Stresses Usability Testing, Risk-Management
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Medtronic Expands in Neurosurgery With $105M Visualase Purchase
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Med-Mizer Warned for MDR Failure After Patient Wedges Head, Dies
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Medical Device User Fee Rates Down Slightly for FY 2015
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FDA Clarifies ‘Substantive Summary,’ ‘Significant Decision’ in Appeals
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Canada’s MEDEC Signs on With Anticorruption Campaign
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OIG Study on DMEPOS Bidding Requested as Expansion Looms
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FDA Rejects Combo Pain Product, Asks for More Bench Testing
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Guidance: CDx Sponsors Should Meet Early With FDA on Submission Type
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Panel Smacks Down Cancer Treatment; Lack of Safety, Efficacy Data at Issue
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FDA Unveils Plans to Regulate LDTs; Launch Set for 6 Months after Final Guidance
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openFDA Shines Light on Two Decades of Incident Reports
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