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FDA Issues UDI Compliance Doc Designed to Help Small Entities
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CDRH Pilot Would Let Submitters View 510(k) Status Online
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FDA, CMS Approve First Product Under Pilot Joint Parallel Review Program
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Success With De Novo Pathway Tied to Strong Presubmission Process
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Kidney Tray Maker Warned on ID Labels, Quality Lapses
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Substantial Equivalence Guidance At Heart of Rejected Petition
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FDA Exempts Slew of Class I/II Devices From 510(k) Review
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South Korea OKs Third-Party Audits for Some Compliant Devicemakers
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EC Panel Recommends Phased Approach to Risk Evaluation of Nanomaterials
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Senators Urge Obama to Use Executive Powers to Stop Corporate Inversions
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Monopoly Case Against Medtronic Remanded to District Court
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China Gives Industry Little Time to Comply With Bevy of New Device Regulations
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