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Added Discussion Paper and Appendix 1 to Public Workshop – Robotically-Assisted Surgical Devices: Challenges and Opportunities, July 27
The Food and Drug Administration (FDA) is announcing a public Workshop entitled: “Robotically-Assisted Surgical (RAS) Devices: Challenges and Opportunities.” The purpose of this workshop is to obtain public feedback on scientific, clinical and regulatory considerations associated with RAS devices. Comments and suggestions generated through this workshop will facilitate further development of regulatory science for RAS…
Consumer Information on: Elecsys® Anti-HCV II Immunoassay and Elecsys® PreciControl Anti-HCV
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Use of LARIAT Suture Delivery Device for Left Atrial Appendage Closure: FDA Safety Communication
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Consumer Information on: VENTANA ALK (D5F3) CDx Assay
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Summary Information for: Brio Neurostimulation System
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Summary Information for: Elecsys® Anti-HCV II Immunoassay and Elecsys® PreciControl Anti-HCV
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Summary Information for: VENTANA ALK (D5F3) CDx Assay
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Heparin-Containing Medical Devices and Combination Products: Recommendations for Labeling and Safety Testing
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Public Workshop ? Acute Ischemic Stroke Medical Devices Trials Workshop, October 6, 2015
The Food and Drug Administration (FDA) is announcing a public Workshop “Acute Ischemic Stroke Medical Devices Trials.” The purpose of this workshop is to obtain public input and feedback on scientific, clinical, and regulatory considerations associated with acute ischemic stroke medical devices. Ideas generated during this workshop may facilitate further development of guidance regarding the…