document.write("<h4>November 6, 2009</h4><ul>");




  
  
    
  
  document.write("<li><a href=\"http://edocket.access.gpo.gov/2009/E9-26737.htm\">Federal Register: Guidance for Industry and Food and Drug Administration Staff; In Vitro Diagnostic 2009 H1N1 Tests for Use in the 2009 H1N1 Emergency; Availability</a></li>");







  
  
    
  
  document.write("<li><a href=\"http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm189467.htm\">Class I Medical Device Recall: Pointe Scientific, Inc., Liquid Glucose Hexokinase Reagent (G7517)</a></li>");




  
  document.write("</ul>")
  document.write("<h4>November 5, 2009</h4><ul>");




  
  
    
  
  document.write("<li><a href=\"http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/510kClearances/ucm189265.htm\">510(k) Final Decisions - October 2009</a></li>");







  
  
    
  
  document.write("<li><a href=\"http://edocket.access.gpo.gov/2009/E9-26674.htm\">Federal Register: Amendment to Memorandum of Understanding Between the Food and Drug Administration and WebMD, LLC</a></li>");







  
  
  document.write("<li><a href=\"http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm189259.htm\">Energy Levels in External Biphasic Defibrillators: Initial Communication</a></li>");







  
  
  document.write("<li><a href=\"http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm189298.htm\">Guidance for Industry and FDA Staff - In Vitro Diagnostic 2009 H1N1 Tests for Use in the 2009 H1N1 Emergency</a></li>");







  
  
    
  
  document.write("<li><a href=\"http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm189301.htm\">Consumer Information on: VIDAS fPSA rt Assay  - P080008</a></li>");







  
  
    
  
  document.write("<li><a href=\"http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num=P080008\">Summary Information for: VIDAS free PSA rt (fPSA) Assay</a></li>");




  
  document.write("</ul>")
  document.write("<h4>November 4, 2009</h4><ul>");




  
  
    
  
  document.write("<li><a href=\"http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm188972.htm\">Class I Medical Device Recall: Centurion Medical Products - Premie Pack and Meconium Pack</a></li>");







  
  
  document.write("<li><a href=\"http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm189111.htm\">Reminder from FDA: Cybersecurity for Networked Medical Devices is a Shared Responsibility</a></li>");




  
  document.write("</ul>")
  document.write("<h4>November 3, 2009</h4><ul>");




  
  
    
  
  document.write("<li><a href=\"http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm188795.htm\">Class I Medical Device Recall: ConvaTec doing business as Unomedical, Inc., Manual Pulmonary Resuscitator (MPR) (Single-Patient Use)</a></li>");




  
  document.write("</ul>")
  document.write("<h4>November 2, 2009</h4><ul>");




  
  
    
  
  document.write("<li><a href=\"http://edocket.access.gpo.gov/2009/E9-26260.htm\">Federal Register: Ear, Nose, and Throat Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting</a></li>");







  
  
    
  
  document.write("<li><a href=\"http://edocket.access.gpo.gov/2009/E9-26259.htm\">Federal Register: Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting</a></li>");







  
  
    
  
  document.write("<li><a href=\"http://edocket.access.gpo.gov/2009/E9-26261.htm\">Federal Register: Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Postponement of Meeting</a></li>");




  
  document.write("</ul>")
  document.write("<h4>October 27, 2009</h4><ul>");




  
  
    
  
  document.write("<li><a href=\"http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/PMAApprovals/ucm188127.htm\">PMA Final Decisions for September 2009</a></li>");




  
  document.write("</ul>")
  document.write("<h4>October 22, 2009</h4><ul>");




  
  
    
  
  document.write("<li><a href=\"http://edocket.access.gpo.gov/2009/E9-25395.htm\">Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002</a></li>");







  
  
    
  
  document.write("<li><a href=\"http://edocket.access.gpo.gov/2009/E9-25406.htm\">Federal Register: Radiological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting</a></li>");




  
  document.write("</ul>")
  document.write("<h4>October 21, 2009</h4><ul>");




  
  
    
  
  document.write("<li><a href=\"http://edocket.access.gpo.gov/2009/E9-25233.htm\">Federal Register: Draft Guidances for Industry and FDA Staff; CADe 510(k) Draft Guidance and CADe Clinical Performance Assessment Draft Guidance</a></li>");







  
  
    
  
  document.write("<li><a href=\"http://edocket.access.gpo.gov/2009/E9-25313.htm\">Federal Register: Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Cardiac Allograft Gene Expression Profiling Test Systems; Availability</a></li>");







  
  
    
  
  document.write("<li><a href=\"http://edocket.access.gpo.gov/2009/E9-25315.htm\">Federal Register: Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Cardiac Allograft Gene Expression Profiling Test Systems</a></li>");




  
  document.write("</ul>")
  document.write("<h4>October 20, 2009</h4><ul>");




  
  
    
  
  document.write("<li><a href=\"http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm185723.htm\">FDA Consumer: A New Online Guide to Hearing Aids</a></li>");







  
  
    
  
  document.write("<li><a href=\"http://edocket.access.gpo.gov/2009/E9-25178.htm\">Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance on Informed Consent For In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not Individually Identifiable</a></li>");







  
  
    
  
  document.write("<li><a href=\"http://edocket.access.gpo.gov/2009/E9-25177.htm\">Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Recommendations for Clinical Laboratory Improvement Amendments of 1988 Waiver Applications</a></li>");







  
  
  document.write("<li><a href=\"http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm187277.htm\">Draft Guidance for Industry and FDA Staff: Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Approval (PMA) and Premarket Notification [510(k)] Submis.</a></li>");







  
  
  document.write("<li><a href=\"http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm187249.htm\">Draft Guidance for Industry and FDA Staff: Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)] Submissions</a></li>");







  
  
  document.write("<li><a href=\"http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm187084.htm\">Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Cardiac Allograft Gene Expression Profiling Test Systems</a></li>");







  
  
    
  
  document.write("<li><a href=\"http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm185459.htm\">FDA Consumer: Hearing Aids and Personal Sound Amplifiers: Know the Difference</a></li>");







  
  
  document.write("<li><a href=\"http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/HomeHealthandConsumer/ConsumerProducts/HearingAids/default.htm\">Information on Hearing Aids</a></li>");







  
  
    
  
  document.write("<li><a href=\"http://edocket.access.gpo.gov/2009/E9-25179.htm\">Federal Register: Medical Device User Fee and Modernization Act; Notice to Public of Web Location of 2010 Proposed Guidance Development</a></li>");




  
  document.write("</ul>")
  document.write("<h4>October 19, 2009</h4><ul>");




  
  
  document.write("<li><a href=\"http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm187078.htm\">Safety Investigation of Certain Medical Device Power Cords: Initial Communication</a></li>");




  
  document.write("</ul>")
  document.write("<h4>October 16, 2009</h4><ul>");




  
  
    
  
  document.write("<li><a href=\"http://edocket.access.gpo.gov/2009/E9-24921.htm\">Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Detention and Banned Medical Devices</a></li>");







  
  
    
  
  document.write("<li><a href=\"http://edocket.access.gpo.gov/2009/E9-24964.htm\">Federal Register: Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Wound Dressing With Poly (Diallyl Dimethyl Ammonium Chloride) Additive; Availability</a></li>");







  
  
    
  
  document.write("<li><a href=\"http://edocket.access.gpo.gov/2009/E9-24967.htm\">Federal Register: Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications</a></li>");







  
  
    
  
  document.write("<li><a href=\"http://edocket.access.gpo.gov/2009/E9-24963.htm\">Federal Register: Medical Devices; Plastic Surgery Devices; Classification of Wound Dressing With Poly (Diallyl Dimethyl Ammonium Chloride) Additive</a></li>");







  
  
    
  
  document.write("<li><a href=\"http://edocket.access.gpo.gov/2009/E9-24895.htm\">Federal Register: National Mammography Quality Assurance Advisory Committee; Notice of Postponement of Meeting</a></li>");







  
  
    
  
  document.write("<li><a href=\"http://edocket.access.gpo.gov/2009/E9-24896.htm\">Federal Register: Request for Nominations for Voting Members on Public Advisory Panels or Committees</a></li>");







  
  
    
  
  document.write("<li><a href=\"http://edocket.access.gpo.gov/2009/E9-24893.htm\">Federal Register: The Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting</a></li>");




  
  document.write("</ul>")
  document.write("<h4>October 15, 2009</h4><ul>");




  
  
    
  
  document.write("<li><a href=\"http://edocket.access.gpo.gov/2009/E9-24828.htm\">Federal Register: Advancing Clinical Development of Molecular and Other Diagnostic Tests for Respiratory Tract Infections; Notice of Public Workshop</a></li>");







  
  
    
  
  document.write("<li><a href=\"http://edocket.access.gpo.gov/2009/E9-24825.htm\">Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device User Fee Cover Sheet; Form FDA 3601</a></li>");







  
  
  document.write("<li><a href=\"http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm186571.htm\">Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Wound Dressing with Poly(diallyl dimethyl ammonium chloride) (pDADMAC) Additive</a></li>");




  
  document.write("</ul>")
  document.write("<h4>October 13, 2009</h4><ul>");




  
  
    
  
  document.write("<li><a href=\"http://edocket.access.gpo.gov/2009/E9-24544.htm\">Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance on Reagents for Detection of Specific Novel Influenza A Viruses</a></li>");




  
  document.write("</ul>")
  document.write("<h4>October 9, 2009</h4><ul>");




  
  
    
  
  document.write("<li><a href=\"http://edocket.access.gpo.gov/2009/E9-24435.htm\">Federal Register: Draft Guidance for Industry and Food and Drug Administration Staff: Mammography Quality Standards Act Final Regulations, etc.</a></li>");







  
  
  document.write("<li><a href=\"http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM185904.pdf\">Draft Guidance for Industry, MQSA Inspectors and FDA Staff - The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #13</a></li>");







  
  
  document.write("<li><a href=\"http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm180307.htm\">Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Respiratory Viral Panel Multiplex Nucleic Acid Assay</a></li>");







  
  
  document.write("<li><a href=\"http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm180306.htm\">Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Testing for Detection and Differentiation of Influenza A Virus Subtypes Using Multiplex Assays</a></li>");







  
  
  document.write("<li><a href=\"http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm180308.htm\">Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Testing for Human Metapneumovirus (hMPV) Using Nucleic Acid Assays</a></li>");







  
  
    
  
  document.write("<li><a href=\"http://edocket.access.gpo.gov/2009/E9-24431.htm\">Federal Register: Guidances for Industry and Food and Drug Administration Staff: Class II Special Controls Guidance Documents; Respiratory Viral Panel Multiplex Nucleic Acid Assay, etc.</a></li>");







  
  
    
  
  document.write("<li><a href=\"http://edocket.access.gpo.gov/2009/E9-24432.htm\">Federal Register: Medical Devices; Immunology and Microbiology Devices; Classification of Respiratory Viral Panel Multiplex Nucleic Acid Assay</a></li>");




  
  document.write("</ul>")
  document.write("<h4>October 8, 2009</h4><ul>");




  
  
  document.write("<li><a href=\"http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm185871.htm\">Guidance for Industry and FDA Staff - Implementation of Medical Device Establishment Registration and Device Listing Requirements Established by the Food and Drug Administration Amendments Act of 2007</a></li>");







  
  
    
  
  document.write("<li><a href=\"http://edocket.access.gpo.gov/2009/E9-24349.htm\">Federal Register: Guidance for Industry and Food and Drug Administration Staff; Availability: Implementation of Medical Device Establishment Registration, etc.</a></li>");







  
  
  document.write("<li><a href=\"http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm185898.htm\">Safety Investigation of CT Brain Perfusion Scans: Initial Notification</a></li>");



document.write("</ul><p align=\"right\">Updated November 7, 2009</p>");