FCE News https://fcenews.it/index.php?option=com_content&view=category&id=1021&layout=blog&Itemid=146 Fri, 24 Jun 2016 09:35:08 +0000 Joomla! 1.5 - Open Source Content Management it-it Emergency Use Authorizations: Zika Virus RNA Qualitative Real-Time RT-PCR (Focus Diagnostics) https://fcenews.it/index.php?option=com_content&view=article&id=210189:emergency-authorizations-zika-virus&catid=1021:radiodiagnostica&Itemid=146 https://fcenews.it/index.php?option=com_content&view=article&id=210189:emergency-authorizations-zika-virus&catid=1021:radiodiagnostica&Itemid=146 On April 28, 2016 the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of Focus Diagnostics, Inc.'s, Zika Virus RNA Qualitative Real-Time RT-PCR test for the qualitative detection of RNA from Zika virus in human ser ... ...]]> [email protected] (CDRH New ) Radiodiagnostica Fri, 29 Apr 2016 08:00:00 +0000 Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN150009 added) https://fcenews.it/index.php?option=com_content&view=article&id=210190:evaluation-automatic-class-designation&catid=1021:radiodiagnostica&Itemid=146 https://fcenews.it/index.php?option=com_content&view=article&id=210190:evaluation-automatic-class-designation&catid=1021:radiodiagnostica&Itemid=146 Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN150009 added) ... ...]]> [email protected] (CDRH New ) Radiodiagnostica Fri, 29 Apr 2016 08:00:00 +0000 Notice of Meeting; Establishment of a Public Docket; Request for Comments: June 2-3, 2016 Circulatory System Devices Panel of the Medical Devices Advisory Committee https://fcenews.it/index.php?option=com_content&view=article&id=210191:notice-meeting-establishment-public&catid=1021:radiodiagnostica&Itemid=146 https://fcenews.it/index.php?option=com_content&view=article&id=210191:notice-meeting-establishment-public&catid=1021:radiodiagnostica&Itemid=146 Notice of Meeting; Establishment of a Public Docket; Request for Comments: June 2-3, 2016 Circulatory System Devices Panel of the Medical Devices Advisory Committee ... ...]]> [email protected] (CDRH New ) Radiodiagnostica Fri, 29 Apr 2016 08:00:00 +0000 Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Requests for Clinical Laboratory Improvement Amendments Categorization https://fcenews.it/index.php?option=com_content&view=article&id=210192:federal-register-agency-information&catid=1021:radiodiagnostica&Itemid=146 https://fcenews.it/index.php?option=com_content&view=article&id=210192:federal-register-agency-information&catid=1021:radiodiagnostica&Itemid=146 The FDA is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register conc ... ...]]> [email protected] (CDRH New ) Radiodiagnostica Fri, 29 Apr 2016 08:00:00 +0000 Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN140018, DEN150030 added) https://fcenews.it/index.php?option=com_content&view=article&id=210193:evaluation-automatic-class-designation&catid=1021:radiodiagnostica&Itemid=146 https://fcenews.it/index.php?option=com_content&view=article&id=210193:evaluation-automatic-class-designation&catid=1021:radiodiagnostica&Itemid=146 Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN140018, DEN150030 added) ... ...]]> [email protected] (CDRH New ) Radiodiagnostica Fri, 29 Apr 2016 08:00:00 +0000 Federal Register: Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior; Proposed Rule https://fcenews.it/index.php?option=com_content&view=article&id=210194:federal-register-banned-devices&catid=1021:radiodiagnostica&Itemid=146 https://fcenews.it/index.php?option=com_content&view=article&id=210194:federal-register-banned-devices&catid=1021:radiodiagnostica&Itemid=146 The FDA is proposing to ban electrical stimulation devices used to treat aggressive or self-injurious behavior. FDA has determined that these devices present an unreasonable and substantial risk of illness or injury that cannot be corrected or elimin ... ...]]> [email protected] (CDRH New ) Radiodiagnostica Fri, 29 Apr 2016 08:00:00 +0000 Presentations and Webcast Archive added to Public Workshop - Streamlining Good Manufacturing Practices (GMPs) for Hearing Aids, April 21, 2016 https://fcenews.it/index.php?option=com_content&view=article&id=210195:presentations-webcast-archive-added&catid=1021:radiodiagnostica&Itemid=146 https://fcenews.it/index.php?option=com_content&view=article&id=210195:presentations-webcast-archive-added&catid=1021:radiodiagnostica&Itemid=146 The Food and Drug Administration (FDA) announced the following public workshop titled "Streamlining Good Manufacturing Practices (GMPs) for Hearing Aids." The topic discussed was the appropriate level of Good Manufacturing Practices (GMPs) ... ...]]> [email protected] (CDRH New ) Radiodiagnostica Fri, 29 Apr 2016 08:00:00 +0000 Federal Register: Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers; Exten https://fcenews.it/index.php?option=com_content&view=article&id=210196:federal-register-refurbishing-reconditioning&catid=1021:radiodiagnostica&Itemid=146 https://fcenews.it/index.php?option=com_content&view=article&id=210196:federal-register-refurbishing-reconditioning&catid=1021:radiodiagnostica&Itemid=146 The FDA is extending the comment period for the document ``Refurbishing Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers'' that ... ...]]> [email protected] (CDRH New ) Radiodiagnostica Fri, 29 Apr 2016 08:00:00 +0000 24 Hour Summary posted for April 20, 2016 Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee https://fcenews.it/index.php?option=com_content&view=article&id=210197:hour-summary-posted-april&catid=1021:radiodiagnostica&Itemid=146 https://fcenews.it/index.php?option=com_content&view=article&id=210197:hour-summary-posted-april&catid=1021:radiodiagnostica&Itemid=146 24 Hour Summary posted for April 20, 2016 Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee ... ...]]> [email protected] (CDRH New ) Radiodiagnostica Fri, 29 Apr 2016 08:00:00 +0000 Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN150058, DEN150028, DEN140024 added) https://fcenews.it/index.php?option=com_content&view=article&id=210198:evaluation-automatic-class-designation&catid=1021:radiodiagnostica&Itemid=146 https://fcenews.it/index.php?option=com_content&view=article&id=210198:evaluation-automatic-class-designation&catid=1021:radiodiagnostica&Itemid=146 Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN150058, DEN150028, DEN140024 added) ... ...]]> [email protected] (CDRH New ) Radiodiagnostica Fri, 29 Apr 2016 08:00:00 +0000