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Emergency Use Authorizations: Zika Virus RNA Qualitative Real-Time RT-PCR (Focus Diagnostics)
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Scritto da CDRH New |
 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 ... ...
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Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN150009 added)
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Scritto da CDRH New |
 Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN150009 added) ... ...
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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
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Scritto da CDRH New |
 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 ... ...
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Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Requests for Clinical Laboratory Improvement Amendments Categorization
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Scritto da CDRH New |
 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 ... ...
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Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN140018, DEN150030 added)
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Scritto da CDRH New |
 Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN140018, DEN150030 added) ... ...
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Federal Register: Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior; Proposed Rule
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Scritto da CDRH New |
 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 ... ...
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Presentations and Webcast Archive added to Public Workshop - Streamlining Good Manufacturing Practices (GMPs) for Hearing Aids, April 21, 2016
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Scritto da CDRH New |
 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) ... ...
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