FCE News https://fcenews.it/index.php 2017-04-04T13:39:27Z Joomla! 1.5 - Open Source Content Management Emergency Use Authorizations: Zika Virus RNA Qualitative Real-Time RT-PCR (Focus Diagnostics) 2016-04-29T08:00:00Z 2016-04-29T08:00:00Z https://fcenews.it/index.php?option=com_content&view=article&id=210189:emergency-authorizations-zika-virus&catid=1021:radiodiagnostica&Itemid=146 CDRH New [email protected] RadiodiagnosticaOn 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 ... ... RadiodiagnosticaOn 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 ... ... Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN150009 added) 2016-04-29T08:00:00Z 2016-04-29T08:00:00Z https://fcenews.it/index.php?option=com_content&view=article&id=210190:evaluation-automatic-class-designation&catid=1021:radiodiagnostica&Itemid=146 CDRH New [email protected] RadiodiagnosticaEvaluation of Automatic Class III Designation (De Novo) Summaries (DEN150009 added) ... ... RadiodiagnosticaEvaluation of Automatic Class III Designation (De Novo) Summaries (DEN150009 added) ... ... 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 2016-04-29T08:00:00Z 2016-04-29T08:00:00Z https://fcenews.it/index.php?option=com_content&view=article&id=210191:notice-meeting-establishment-public&catid=1021:radiodiagnostica&Itemid=146 CDRH New [email protected] RadiodiagnosticaNotice of Meeting; Establishment of a Public Docket; Request for Comments: June 2-3, 2016 Circulatory System Devices Panel of the Medical Devices Advisory Committee ... ... RadiodiagnosticaNotice of Meeting; Establishment of a Public Docket; Request for Comments: June 2-3, 2016 Circulatory System Devices Panel of the Medical Devices Advisory Committee ... ... Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Requests for Clinical Laboratory Improvement Amendments Categorization 2016-04-29T08:00:00Z 2016-04-29T08:00:00Z https://fcenews.it/index.php?option=com_content&view=article&id=210192:federal-register-agency-information&catid=1021:radiodiagnostica&Itemid=146 CDRH New [email protected] RadiodiagnosticaThe 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 ... ... RadiodiagnosticaThe 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 ... ... Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN140018, DEN150030 added) 2016-04-29T08:00:00Z 2016-04-29T08:00:00Z https://fcenews.it/index.php?option=com_content&view=article&id=210193:evaluation-automatic-class-designation&catid=1021:radiodiagnostica&Itemid=146 CDRH New [email protected] RadiodiagnosticaEvaluation of Automatic Class III Designation (De Novo) Summaries (DEN140018, DEN150030 added) ... ... RadiodiagnosticaEvaluation of Automatic Class III Designation (De Novo) Summaries (DEN140018, DEN150030 added) ... ... Federal Register: Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior; Proposed Rule 2016-04-29T08:00:00Z 2016-04-29T08:00:00Z https://fcenews.it/index.php?option=com_content&view=article&id=210194:federal-register-banned-devices&catid=1021:radiodiagnostica&Itemid=146 CDRH New [email protected] RadiodiagnosticaThe 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 ... ... RadiodiagnosticaThe 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 ... ... Presentations and Webcast Archive added to Public Workshop - Streamlining Good Manufacturing Practices (GMPs) for Hearing Aids, April 21, 2016 2016-04-29T08:00:00Z 2016-04-29T08:00:00Z https://fcenews.it/index.php?option=com_content&view=article&id=210195:presentations-webcast-archive-added&catid=1021:radiodiagnostica&Itemid=146 CDRH New [email protected] RadiodiagnosticaThe 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) ... ... RadiodiagnosticaThe 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) ... ... Federal Register: Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers; Exten 2016-04-29T08:00:00Z 2016-04-29T08:00:00Z https://fcenews.it/index.php?option=com_content&view=article&id=210196:federal-register-refurbishing-reconditioning&catid=1021:radiodiagnostica&Itemid=146 CDRH New [email protected] RadiodiagnosticaThe 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 ... ... RadiodiagnosticaThe 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 ... ... 24 Hour Summary posted for April 20, 2016 Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee 2016-04-29T08:00:00Z 2016-04-29T08:00:00Z https://fcenews.it/index.php?option=com_content&view=article&id=210197:hour-summary-posted-april&catid=1021:radiodiagnostica&Itemid=146 CDRH New [email protected] Radiodiagnostica24 Hour Summary posted for April 20, 2016 Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee ... ... Radiodiagnostica24 Hour Summary posted for April 20, 2016 Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee ... ... Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN150058, DEN150028, DEN140024 added) 2016-04-29T08:00:00Z 2016-04-29T08:00:00Z https://fcenews.it/index.php?option=com_content&view=article&id=210198:evaluation-automatic-class-designation&catid=1021:radiodiagnostica&Itemid=146 CDRH New [email protected] RadiodiagnosticaEvaluation of Automatic Class III Designation (De Novo) Summaries (DEN150058, DEN150028, DEN140024 added) ... ... RadiodiagnosticaEvaluation of Automatic Class III Designation (De Novo) Summaries (DEN150058, DEN150028, DEN140024 added) ... ...