January 15, 2009 |
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Federal Register: Institutional Review Boards; Registration Requirements |
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Orthopaedic and Rehabilitation Devices Panel Advisory Meeting, December 9, 2008 - Transcript |
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Federal Register: Unique Device Identification System; Public Workshop; Request for Comments |
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January 14, 2009 |
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FDA Unique Device Identification Public Workshop: February 12, 2009 |
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January 13, 2009 |
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Federal Register: Advisory Committees; Tentative Schedule of Meetings for 2009 |
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Federal Register: Guidance for Industry: Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices; Availability |
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January 12, 2009 |
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Anesthesiology and Respiratory Therapy Devices Panel Advisory Meeting, December 5, 2008 - Transcript |
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Immunology Devices Panel Advisory Meeting, December 3, 2008 - Transcript |
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Orthopaedic and Rehabilitation Devices Panel Advisory Meeting, November 14, 2008 - Transcript |
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January 6, 2009 |
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Federal Register: Draft Guidance for Industry and Food and Drug Administration Staff; Assay Migration Studies for In Vitro Diagnostic Devices; Availability. |
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Guidance for Industry: Designation of Special Controls for Male Condoms Made of Natural Rubber Latex (21 CFR 884.5300); Small Entity Compliance Guide |
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January 5, 2009 |
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510(k) Final Decisions - December 2008 |
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January 2, 2009 |
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Draft Guidance for Industry and FDA Staff: Assay Migration Studies for In Vitro Diagnostic Devices |
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Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Nucleic Acid Amplification Assay for the Detection of Enterovirus RNA |
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Federal Register: Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Nucleic Acid Amplification Assay for the Detection of Enterovirus RNA; Availability. |
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Federal Register: Medical Devices; Immunology and Microbiology Devices; Classification of Enterovirus Nucleic Acid Assay. |
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December 30, 2008 |
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Guidance for Industry and FDA Staff: Radiation Safety Considerations for X-Ray Equipment Designed for Hand-Held Use |
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December 24, 2008 |
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Class I Medical Device Recall: Stryker Leibinger USA., Stryker Custom Cranial Implant Kits |
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December 23, 2008 |
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Federal Register: Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300; Availability |
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December 22, 2008 |
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Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Emergency Shortages Data Collection System (formerly Emergency Medical Device Shortages Program Survey) |
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Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Recall Authority |
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Circulatory System Devices Panel Advisory Meeting, November 20, 2008 - Transcript |
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General and Plastic Surgery Devices Panel Advisory Meeting, November 18-19, 2008 - Transcript |
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Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300 |
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December 19, 2008 |
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Federal Register: Agency Information Collection Activities ; Proposed Collection; Comment Request; Medical Device Recall Authority. |
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Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Emergency Shortages Data Collection System (formerly “Emergency Medical Device Shortages Program Survey”). |
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Summary Information for: Bard® ELUMINEXX Vascular Stent |
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Summary Information for: Boston Scientific Express® SD Renal Monorail® Premounted Stent System |
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Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Tissue Expander |
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Class I Medical Device Recall: Sun Med Greenline/D MacIntosh No. 3 Laryngoscope Blades |
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