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General Wellness: Policy for Low Risk Devices
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Webinar Presentation and Transcript added to Final Guidance on Use of International Standard ISO 10993-1, Biological evaluation of medical devices
On July 21, 2016, the FDA will hold a webinar for industry to review the Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process” final guidance document. The recommendations in this final guidance clarify and update how medical device developers may use…
Adaptive Designs for Medical Device Clinical Studies
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Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN150030 added)
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Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices
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Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI)
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24 Hour Summary (Dexcom) posted for July 21, 2016 Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee
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Patient and Provider Notification (PPN): What to expect if your facility is ordered to perform a PPN
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Presentations posted for July 21-22, 2016 Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee
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