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	Federal Register: Draft Guidance for Industry and Food and Drug Administration Staff; Assay Migration Studies for In Vitro Diagnostic Devices; Availability.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	Draft Guidance for Industry and FDA Staff: Assay Migration Studies for In Vitro Diagnostic Devices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

Updated January 16, 2009

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