DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-0722] Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting…
Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling
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FDA Press Release: FDA releases final guidance on reprocessing of reusable medical devices
The U.S. Food and Drug Administration today announced new actions to enhance the safety of reusable medical devices and address the possible spread of infectious agents between uses. The new recommendations are outlined in a final industry guidance aimed at helping device manufacturers develop safer reusable devices, especially those devices that pose a greater risk…
Consumer Information on: TissuGlu Surgical Adhesive
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Public Workshop ? FCC/FDA Joint Workshop on Wireless Medical Device Test Beds, March 31, 2015
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…
New National Medical Device Curriculum Case Study: 6.Using the De Novo Process to Classify and Bring to Market an Innovative, Low-to-Moderate Risk Device
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Public Workshop
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…
Meeting Presentations posted for February 27, 2015 General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee
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Workshop – 8th Annual Medical Device and Diagnostics Statistical Issues, Co-Sponsored by AdvaMed and FDA, April 29
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Class I Medical Device Recall: Hospira Plum A+ and Plum A+3 Infusion Systems Alarm Volume Failure
Recall Class: Class I Date Recall Initiated: May 28, 2014 Devices: Plum A+ infusion pumps and Plum A+3 infusion pumps A full list of products being recalled can be found at:http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130257http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130256 Manufacturing and Distribution dates: July 2012 to May 2014 Use: An infusion pump is a medical device that delivers fluids, such as nutrients and…