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: VENTANA ALK (D5F3) CDx Assay

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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…