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Class I Medical Device Recall: Thornhill Research Inc. Recalls MOVES Ventilator System Due to Battery Problem
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Class I Medical Device Recall: St. Jude Medical Recalls Optisure Dual Coil Defibrillation Leads Due to Damage that May Prevent Patient Therapy
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Updated Information on MRI (Magnetic Resonance Imaging)
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Day 2 Presentation Added to Public Workshop – Moving Forward: Collaborative Approaches to Medical Device Cybersecurity, January 20
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Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices
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Day 1 Presentation Added to Public Workshop – Moving Forward: Collaborative Approaches to Medical Device Cybersecurity, January 20
The Food and Drug Administration (FDA) is announcing the following public workshop titled “Moving Forward: Collaborative Approaches to Medical Device Cybersecurity.” FDA, in collaboration with the National Health Information Sharing Analysis Center (NH-ISAC), the Department of Health and Human Services and the Department of Homeland Security, seek to bring together diverse stakeholders to discuss complex…
Day 1 Presentation Added to Public Workshop – Moving Forward: Collaborative Approaches to Medical Device Cybersecurity, January 20
The Food and Drug Administration (FDA) is announcing the following public workshop titled “Moving Forward: Collaborative Approaches to Medical Device Cybersecurity.” FDA, in collaboration with the National Health Information Sharing Analysis Center (NH-ISAC), the Department of Health and Human Services and the Department of Homeland Security, seek to bring together diverse stakeholders to discuss complex…
PMA Final Decisions for November 2015
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Public Workshop
The Food and Drug Administration (FDA) is announcing the following public workshop entitled “Point of Care Prothrombin Time/International Normalized Ratio Devices for Monitoring Warfarin Therapy.” The purpose of this workshop is to discuss and receive input from stakeholders regarding approaches to the analytical and clinical validation of point of care (POC) Prothrombin Time/International Normalized Ratio…