DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-0001] Ear, Nose, and Throat Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice AGENCY:  Food and Drug Administration, HHS. ACTION:  Notice. SUMMARY:  The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Ear,…

Washington, D.C. – On Tuesday, March 31, 2015, the Federal Communications Commission and the Food and Drug Administration will host a public workshop on the role of wireless medical test beds and their influence on the development of converged medical technology for clinical and non-clinical settings. A wireless test bed is an environment where devices…

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Date Issued: March 26, 2015 Audience: Users of the Olympus TJF-Q180V and reprocessing facilities including: Gastroenterologists Gastrointestinal surgeons Endoscopy nurses Staff working in endoscopy reprocessing units in health care facilities Infection control practitioners Facility risk managers Medical Specialties: Gastroenterology, Infection Control Device: Olympus Duodenoscope model TJF-Q180V Olympus has issued new, validated manual reprocessing instructions for…

This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval. Product Name: TECNIS Multifocal 1-Piece Intraocular Lens…

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The purpose of the workshop is to facilitate an in-depth discussion of harmonization of companion diagnostic devices across a class of targeted therapies. The workshop aims to foster collaborations in the clinical cancer research community; provide a deeper understanding of anticancer drug and device development related to personalized medicine; provide a unique perspective of personalized…