2006N-0362: General and Plastic Surgery Devices; Reclassification of the Absorbable Hemostatic Device

BKG1 Table of Contents

Letter to Panel Member (pdf)

Tab 1: Device Classification/Reclassification Procedures, Jarjorie Shulman (pdf)

Tab 2: Memorandum from FDA to Panel Member (pdf)

Tab 3: Reclassification Issues (pdf)

Tab 4: Sample Guidance Document (pdf)

Tab 5: Copyrighted Material - can be viewed at the Dockets Management Public Reading Room, 5630 Fishers Lane, Room 1061, Rockville, Maryland 20852

Tab 6: Provisions of the FDA Modernization Act of 1997: Concept and Principles; Final Guidance for FDA and Industry, October 4, 2002 (pdf)

Tab 7: Sample Labeling of SURGIFOAM Sponge (Sterile) (pdf)