id,agency_id,docket_id,title,document_type,subtype,posted_date,posted_year,posted_month,comment_start_date,comment_end_date,last_modified,fr_doc_num,open_for_comment,withdrawn,object_id
FDA-2023-N-3392-0019,FDA,FDA-2023-N-3392,"Reference 17 - Hutchings M., A. Truman, and B. Wilkinson, “Antibiotics: Past, Present and Future,” Current Opinion in Microbiology",Supporting & Related Material,Background Material,2023-12-07T05:00:00Z,2023,12,,,2023-12-07T23:08:14Z,,0,0,090000648630c910
FDA-2023-N-3392-0035,FDA,FDA-2023-N-3392,"Reference 33 - Leonel C., I. Sena, W. Silva, et al., “Staphylococcus Epidermidis Role in the Skin Microenvironment,” Journal of Cellular And Molecular Medicine",Supporting & Related Material,Background Material,2023-12-07T05:00:00Z,2023,12,,,2023-12-07T23:13:08Z,,0,0,090000648630cbac
FDA-2023-N-3392-0005,FDA,FDA-2023-N-3392,"Reference 3 - General and Plastic Surgery Devices Panel, “2016 Meeting Materials of the General and Plastic Surgery Advisory Panel--September 20-21, 2016”",Supporting & Related Material,Background Material,2023-12-07T05:00:00Z,2023,12,,,2023-12-07T23:04:06Z,,0,0,090000648630c213
FDA-2023-N-3392-0007,FDA,FDA-2023-N-3392,"Reference 5 - Sen C., G. Gordillo, S. Roy, et al., “Human Skin Wounds: A Major and Snowballing Threat to Public Health and the Economy,” Wound Repair and Regeneration",Supporting & Related Material,Background Material,2023-12-07T05:00:00Z,2023,12,,,2023-12-07T23:04:40Z,,0,0,090000648630c215
FDA-2023-N-3392-0012,FDA,FDA-2023-N-3392,"Reference 10 - Hess C.T., “Putting the Squeeze on Venous Ulcers,” Nursing",Supporting & Related Material,Background Material,2023-12-07T05:00:00Z,2023,12,,,2023-12-07T23:06:00Z,,0,0,090000648630c368
FDA-2023-N-3392-0016,FDA,FDA-2023-N-3392,"Reference 14 - Gottrup F., J. Apelqvist, T. Bjarnsholt, et al., “Antimicrobials and Non-Healing Wounds: Evidence, Controversies, and Suggestions--Key Messages,” Journal of Wound Care",Supporting & Related Material,Background Material,2023-12-07T05:00:00Z,2023,12,,,2023-12-07T23:07:06Z,,0,0,090000648630c439
FDA-2023-N-3392-0020,FDA,FDA-2023-N-3392,"Reference 18 - CDC, Antibiotic Resistance Threats in the United States 2019 Report",Supporting & Related Material,Background Material,2023-12-07T05:00:00Z,2023,12,,,2023-12-07T23:08:26Z,,0,0,090000648630c913
FDA-2023-N-3392-0031,FDA,FDA-2023-N-3392,"Reference 29 - Government of Canada, “Categorization of Antimicrobial Drugs Based on Importance in Human Medicine,” 2009",Supporting & Related Material,Background Material,2023-12-07T05:00:00Z,2023,12,,,2023-12-07T23:12:01Z,,0,0,090000648630ca93
FDA-2023-N-3392-0004,FDA,FDA-2023-N-3392,"Reference 2 - General and Plastic Surgery Devices Panel, “Brief Summary from the General and Plastic Surgery Devices Panel Meeting--August 25-26, 2005”",Supporting & Related Material,Background Material,2023-12-07T05:00:00Z,2023,12,,,2023-12-07T23:03:43Z,,0,0,090000648630bc20
FDA-2023-N-3392-0025,FDA,FDA-2023-N-3392,"Reference 23 - Munita J. and C. Arias, “Mechanisms of Antibiotic Resistance,” Microbiology Spectrum",Supporting & Related Material,Background Material,2023-12-07T05:00:00Z,2023,12,,,2023-12-07T23:10:16Z,,0,0,090000648630c9ee
FDA-2023-N-3392-0039,FDA,FDA-2023-N-3392,"Reference 37 - Burke T., M. Rupp, P. Fey, “Staphylococcus Epidermidis,” Trends in Microbiology",Supporting & Related Material,Background Material,2023-12-07T05:00:00Z,2023,12,,,2023-12-07T23:14:23Z,,0,0,090000648630cbb0
FDA-2023-N-3392-0013,FDA,FDA-2023-N-3392,"Reference 11 - Driver V., M. Fabbi, L. Lavery, et al., “The Costs of Diabetic Foot: The Economic Case for the Limb Salvage Team,” Journal of Vascular Surgery",Supporting & Related Material,Background Material,2023-12-07T05:00:00Z,2023,12,,,2023-12-07T23:06:18Z,,0,0,090000648630c36d
FDA-2023-N-3392-0043,FDA,FDA-2023-N-3392,"Reference 41 -  Choi Y., K. Campbell, C. Levek, et al., “Antibiotic Ointment Versus a Silver-Based Dressing for Children With Extremity Burns: A Randomized Controlled Study,” Journal of Pediatric Surgery",Supporting & Related Material,Background Material,2023-12-07T05:00:00Z,2023,12,,,2023-12-07T23:15:30Z,,0,0,090000648630cc34
FDA-2023-N-3392-0055,FDA,FDA-2023-N-3392,"Reference 53 - Luqman A., M. Muttaqin, S. Yulaipi, et al., “Trace Amines Produced by Skin Bacteria Accelerate Wound Healing in Mice,” Communications Biology",Supporting & Related Material,Background Material,2023-12-07T05:00:00Z,2023,12,,,2023-12-07T23:19:29Z,,0,0,090000648630d2a9
FDA-2023-N-3392-0021,FDA,FDA-2023-N-3392,"Reference 19 - Dadgostar P., “Antimicrobial Resistance: Implications and Costs.,” Infection and Drug Resistance",Supporting & Related Material,Background Material,2023-12-07T05:00:00Z,2023,12,,,2023-12-07T23:09:03Z,,0,0,090000648630c915
FDA-2023-N-3392-0048,FDA,FDA-2023-N-3392,"Reference 46 - Serena T., L. Serena, O. Al-Jalodi, et al., “The Efficacy of Sodium Hypochlorite Antiseptic: A Double-Blind, Randomised Controlled Pilot Study,” Journal of Wound Care",Supporting & Related Material,Background Material,2023-12-07T05:00:00Z,2023,12,,,2023-12-07T23:17:11Z,,0,0,090000648630d115
FDA-2023-N-3392-0049,FDA,FDA-2023-N-3392,"Reference 47 - Saad A., E. Salazar, L. Allen, et al., “Antimicrobial Dressing Versus Standard Dressing in Obese Women Undergoing Cesarean Delivery: A Randomized Controlled Trial,” American Journal of Perinatology",Supporting & Related Material,Background Material,2023-12-07T05:00:00Z,2023,12,,,2023-12-07T23:17:20Z,,0,0,090000648630d116
FDA-2023-N-3392-0051,FDA,FDA-2023-N-3392,"Reference 49 - Linehanm J., O. Harrison, S. Han, et al., “Non-Classical Immunity Controls Microbiota Impact on Skin Immunity and Tissue Repair,” Cell",Supporting & Related Material,Background Material,2023-12-07T05:00:00Z,2023,12,,,2023-12-07T23:17:57Z,,0,0,090000648630d119
FDA-2023-N-3392-0053,FDA,FDA-2023-N-3392,"Reference 51 - Leonel C., I. Sena, W. Silva, et al., “Staphylococcus Epidermidis Role in the Skin Microenvironment,” Journal of Cellular and Molecular Medicine",Supporting & Related Material,Background Material,2023-12-07T05:00:00Z,2023,12,,,2023-12-07T23:18:33Z,,0,0,090000648630d2a3
FDA-2023-N-3392-0040,FDA,FDA-2023-N-3392,"Reference 38 - FDA, “Classification of Products as Drugs and Devices & Additional Product Classification Issues: Guidance for Industry and FDA Staff,” September 2017",Supporting & Related Material,Background Material,2023-12-07T05:00:00Z,2023,12,,,2023-12-07T23:14:36Z,,0,0,090000648630cc31
FDA-2023-N-3392-0015,FDA,FDA-2023-N-3392,"Reference 13 - Guo S. and L.A. DiPietro, “Factors Affecting Wound Healing,” Journal of Dental Research",Supporting & Related Material,Background Material,2023-12-07T05:00:00Z,2023,12,,,2023-12-07T23:06:53Z,,0,0,090000648630c435
FDA-2023-N-3392-0034,FDA,FDA-2023-N-3392,"Reference 32 - Johnson T., B. Gomez, M. McIntyre, et al., “The Cutaneous Microbiome and Wounds: New Molecular Targets To Promote Wound Healing,” International Journal of Molecular Sciences",Supporting & Related Material,Background Material,2023-12-07T05:00:00Z,2023,12,,,2023-12-07T23:12:58Z,,0,0,090000648630ca9b
FDA-2023-N-3392-0041,FDA,FDA-2023-N-3392,"Reference 39 - FDA, “General and Plastic Surgery Devices; Classification of the Nonresorbable Gauze/Sponge for External Use, the Hydrophilic Wound Dressing, the Occlusive Wound Dressing, and the Hydrogel Wound Dressing,” 64 FR 53927, October 5, 1999",Supporting & Related Material,Background Material,2023-12-07T05:00:00Z,2023,12,,,2023-12-07T23:15:05Z,,0,0,090000648630cc32
FDA-2023-N-3392-0003,FDA,FDA-2023-N-3392,"Reference 1 - General and Plastic Surgery Devices Panel, “Transcript of the FDA General and Plastic Surgery Devices Panel meeting - November 17, 1998""",Supporting & Related Material,Background Material,2023-12-07T05:00:00Z,2023,12,,,2023-12-07T23:03:11Z,,0,0,090000648630bc1f
FDA-2023-N-3392-0002,FDA,FDA-2023-N-3392,List of References,Supporting & Related Material,Background Material,2023-12-07T05:00:00Z,2023,12,,,2023-12-07T23:02:58Z,,0,0,090000648630bc1c
FDA-2023-N-3392-0006,FDA,FDA-2023-N-3392,"Reference 4 - WHO, “Critically Important Antimicrobials For Human Medicine: 6th Revision”",Supporting & Related Material,Background Material,2023-12-07T05:00:00Z,2023,12,,,2023-12-07T23:04:24Z,,0,0,090000648630c214
FDA-2023-N-3392-0008,FDA,FDA-2023-N-3392,"Reference 6 - Nussbaum S., M. Carter, C. Fife, et al., “An Economic Evaluation of the Impact, Cost, and Medicare Policy Implications of Chronic Nonhealing Wounds,” Value in Health",Supporting & Related Material,Background Material,2023-12-07T05:00:00Z,2023,12,,,2023-12-07T23:05:02Z,,0,0,090000648630c217
FDA-2023-N-3392-0037,FDA,FDA-2023-N-3392,"Reference 35 - Luqman A., M. Muttaqin, S. Yulaipi, et al., “Trace Amines Produced by Skin Bacteria Accelerate Wound Healing in Mice,” Communications Biology",Supporting & Related Material,Background Material,2023-12-07T05:00:00Z,2023,12,,,2023-12-07T23:13:47Z,,0,0,090000648630cbae
FDA-2023-N-3392-0038,FDA,FDA-2023-N-3392,"Reference 36- Brown M., A. Horswill, “Staphylococcus Epidermidis--Skin Friend or Foe?” PLOS Pathogens",Supporting & Related Material,Background Material,2023-12-07T05:00:00Z,2023,12,,,2023-12-07T23:14:13Z,,0,0,090000648630cbaf
FDA-2023-N-3392-0028,FDA,FDA-2023-N-3392,"Reference 26 - Peleg A., and D. Hooper. “Hospital-Acquired Infections Due to Gram-Negative Bacteria,” The New England Journal of Medicine",Supporting & Related Material,Background Material,2023-12-07T05:00:00Z,2023,12,,,2023-12-07T23:11:13Z,,0,0,090000648630c9f5
FDA-2023-N-3392-0030,FDA,FDA-2023-N-3392,"Reference 28 - FDA, “Evaluating the Safety of Antimicrobial New Animal Drugs With Regard to Their Microbiological Effects on Bacteria of Human Health Concern: Guidance for Industry,” October 23, 2003",Supporting & Related Material,Background Material,2023-12-07T05:00:00Z,2023,12,,,2023-12-07T23:11:37Z,,0,0,090000648630ca92
FDA-2023-N-3392-0032,FDA,FDA-2023-N-3392,"Reference 30 - McDonnell G., and A. Russell, “Antiseptic and Disinfectants: Activity, Action, and Resistance,” Clinical Microbiology Reviews",Supporting & Related Material,Background Material,2023-12-07T05:00:00Z,2023,12,,,2023-12-07T23:12:10Z,,0,0,090000648630ca95
FDA-2023-N-3392-0042,FDA,FDA-2023-N-3392,"Reference 40 - FDA, “Medical Devices; Plastic Surgery Devices; Classification of Wound Dressing With Poly (Diallyl Dimethyl Ammonium Chloride) Additive,” 74 FR 53165, October 16, 2009",Supporting & Related Material,Background Material,2023-12-07T05:00:00Z,2023,12,,,2023-12-07T23:15:20Z,,0,0,090000648630cc33
FDA-2023-N-3392-0045,FDA,FDA-2023-N-3392,"Reference 43 - Kim D., W. Namen Ii, J. Moore, et al., “Clinical Assessment of a Biofilm-disrupting Agent for the Management of Chronic Wounds Compared With Standard of Care: A Therapeutic Approach,” Wounds",Supporting & Related Material,Background Material,2023-12-07T05:00:00Z,2023,12,,,2023-12-07T23:16:12Z,,0,0,090000648630cc36
FDA-2023-N-3392-0057,FDA,FDA-2023-N-3392,"Reference 55 - Burke T., M. Rupp, P. Fey, “Staphylococcus Epidermidis,” Trends in Microbiology, 2023",Supporting & Related Material,Background Material,2023-12-07T05:00:00Z,2023,12,,,2023-12-07T23:19:47Z,,0,0,090000648630d2c4
FDA-2023-N-3392-0058,FDA,FDA-2023-N-3392,Reference 56 - FDA’s Full Preliminary Analysis of Economic Impacts,Supporting & Related Material,Background Material,2023-12-07T05:00:00Z,2023,12,,,2023-12-07T23:20:10Z,,0,0,090000648630d2c5
FDA-2023-N-3392-0014,FDA,FDA-2023-N-3392,"Reference 12 - Gordon M., M. Gottschlich, E. Helvig, et al., “Review of Evidence-Based Practice for the Prevention of Pressure Sores in Burn Patients,” Journal of Burn Care & Research",Supporting & Related Material,Background Material,2023-12-07T05:00:00Z,2023,12,,,2023-12-07T23:06:41Z,,0,0,090000648630c434
FDA-2023-N-3392-0022,FDA,FDA-2023-N-3392,"Reference 20 - National Quality Forum, “NQF, CDC Issue Guidance To Help Hospitals Better Manage Use of Antibiotics,” 2016",Supporting & Related Material,Background Material,2023-12-07T05:00:00Z,2023,12,,,2023-12-07T23:09:13Z,,0,0,090000648630c916
FDA-2023-N-3392-0024,FDA,FDA-2023-N-3392,"Reference 22 - HHS, “Antimicrobial Resistance”",Supporting & Related Material,Background Material,2023-12-07T05:00:00Z,2023,12,,,2023-12-07T23:10:03Z,,0,0,090000648630c9ed
FDA-2023-N-3392-0029,FDA,FDA-2023-N-3392,"Reference 27 - WHO, “Burns”",Supporting & Related Material,Background Material,2023-12-07T05:00:00Z,2023,12,,,2023-12-07T23:11:24Z,,0,0,090000648630c9f6
FDA-2023-N-3392-0011,FDA,FDA-2023-N-3392,"Reference 9 - Kuhn A., S.J. Coulter, “Balancing Ulcer Cost and Quality Equation,” Nursing Economics",Supporting & Related Material,Background Material,2023-12-07T05:00:00Z,2023,12,,,2023-12-07T23:05:50Z,,0,0,090000648630c21a
FDA-2023-N-3392-0023,FDA,FDA-2023-N-3392,"Reference 21 - CDC, The Core Elements of Hospital Antibiotic Stewardship Programs: 2019",Supporting & Related Material,Background Material,2023-12-07T05:00:00Z,2023,12,,,2023-12-07T23:09:32Z,,0,0,090000648630c919
FDA-2023-N-3392-0036,FDA,FDA-2023-N-3392,"Reference 34 - Pastar I., K. O’Neill, L. Padula, et al., “Staphylococcus Epidermidis Boosts Innate Immune Response by Activation of Gamma Delta T Cells and Induction of Perforin-2 in Human Skin,” Frontiers in Immunology",Supporting & Related Material,Background Material,2023-12-07T05:00:00Z,2023,12,,,2023-12-07T23:13:37Z,,0,0,090000648630cbad
FDA-2023-N-3392-0010,FDA,FDA-2023-N-3392,"Reference 8 - Carter M., C. Fife, D. Walker, et al., “Estimating the Applicability of Wound Care Randomized Controlled Trials to General Wound-Care Populations by Estimating the Percentage of Individuals Excluded from a Typical Wound-Care Population in Such Trials,” Advances in Skin & Wound Care",Supporting & Related Material,Background Material,2023-12-07T05:00:00Z,2023,12,,,2023-12-07T23:05:26Z,,0,0,090000648630c219
FDA-2023-N-3392-0046,FDA,FDA-2023-N-3392,"Reference 44 - Connery S., J. Yankowitz, L. Odibo, et al., “Effect of Using Silver Nylon Dressings To Prevent Superficial Surgical Site Infection After Cesarean Delivery: A Randomized Clinical Trial,” American Journal of Obstetrics and Gynecology",Supporting & Related Material,Background Material,2023-12-07T05:00:00Z,2023,12,,,2023-12-07T23:16:21Z,,0,0,090000648630cc37
FDA-2023-N-3392-0050,FDA,FDA-2023-N-3392,"Reference 48 - Dissemond J., J. Steinmann, K. Münter, et al., “Risk and Clinical Impact of Bacterial Resistance/Susceptibility to Silver-Based Wound Dressings: A Systematic Review,” Journal of Wound Care",Supporting & Related Material,Background Material,2023-12-07T05:00:00Z,2023,12,,,2023-12-07T23:17:30Z,,0,0,090000648630d117
FDA-2023-N-3392-0052,FDA,FDA-2023-N-3392,"Reference 50 - Johnson T., B. Gomez, M. McIntyre, et al., “The Cutaneous Microbiome and Wounds: New Molecular Targets To Promote Wound Healing,” International Journal of Molecular Science",Supporting & Related Material,Background Material,2023-12-07T05:00:00Z,2023,12,,,2023-12-07T23:18:23Z,,0,0,090000648630d11a
FDA-2023-N-3392-0026,FDA,FDA-2023-N-3392,"Reference 24 - Bennett, P.M., “Plasmid Encoded Antibiotic Resistance: Acquisition and Transfer of Antibiotic Resistance Genes in Bacteria,” British Journal of Pharmacology",Supporting & Related Material,Background Material,2023-12-07T05:00:00Z,2023,12,,,2023-12-07T23:10:27Z,,0,0,090000648630c9ef
FDA-2023-N-3392-0044,FDA,FDA-2023-N-3392,"Reference 42 - Benedetto A., J. Staidle, J. Schoenfeld, et al., “Comparing the Use of a Novel Antibiotic-Free Film-Forming Topical Wound Dressing Versus a Topical Triple Antibiotic in Dermatologic Surgical Procedures Including Mohs Micrographic Surgery,” Journal of European Academy of Dermatology and Venereology",Supporting & Related Material,Background Material,2023-12-07T05:00:00Z,2023,12,,,2023-12-07T23:16:02Z,,0,0,090000648630cc35
FDA-2023-N-3392-0056,FDA,FDA-2023-N-3392,"Reference 54 - Brown M., A. Horswill, “Staphylococcus Epidermidis--Skin Friend or Foe?” PLOS Pathogens",Supporting & Related Material,Background Material,2023-12-07T05:00:00Z,2023,12,,,2023-12-07T23:19:37Z,,0,0,090000648630d2aa
FDA-2023-N-3392-0017,FDA,FDA-2023-N-3392,"Reference 15 - Sen, C., “Human Wounds and Its Burden: An Updated Compendium of Estimates,” Advances in Wound Care",Supporting & Related Material,Background Material,2023-12-07T05:00:00Z,2023,12,,,2023-12-07T23:07:26Z,,0,0,090000648630c43a
FDA-2023-N-3392-0027,FDA,FDA-2023-N-3392,"Reference 25 - Chandan P., J. Bengtsson-Palme, E. Kristiansson, et al., “Co-Occurrence of Resistance Genes to Antibiotics, Biocides and Metals Reveals Novel Insights into Their Co-Selection Potential,” BMC Genomics",Supporting & Related Material,Background Material,2023-12-07T05:00:00Z,2023,12,,,2023-12-07T23:10:36Z,,0,0,090000648630c9f2
FDA-2023-N-3392-0018,FDA,FDA-2023-N-3392,"Reference 16 - FDA, “Supporting Antimicrobial Stewardship in Veterinary Settings: Goals for Fiscal Years 2024-2028: Key Phase 3 and Key Phase 4 Actions,” September 2023",Supporting & Related Material,Background Material,2023-12-07T05:00:00Z,2023,12,,,2023-12-07T23:07:37Z,,0,0,090000648630c43b
FDA-2023-N-3392-0047,FDA,FDA-2023-N-3392,"Reference 45 - Ahmad H., K. Kallies, and S. Shapiro, “The Effect of Mupirocin Dressings on Postoperative Surgical Site Infections in Elective Colorectal Surgery: A Prospective, Randomized Controlled Trial,” The American Journal of Surgery",Supporting & Related Material,Background Material,2023-12-07T05:00:00Z,2023,12,,,2023-12-07T23:16:31Z,,0,0,090000648630d114
FDA-2023-N-3392-0054,FDA,FDA-2023-N-3392,"Reference 52 - Pastar I., K. O’Neill, L. Padula, et al., “Staphylococcus Epidermidis Boosts Innate Immune Response by Activation of Gamma Delta T Cells and Induction of Perforin-2 in Human Skin,” Frontiers in Immunology",Supporting & Related Material,Background Material,2023-12-07T05:00:00Z,2023,12,,,2023-12-07T23:18:42Z,,0,0,090000648630d2a7
FDA-2023-N-3392-0009,FDA,FDA-2023-N-3392,"Reference 7 - Berry C., D.R. Murdoch, and J.J. McMurray, “Economics of Chronic Heart Failure,” European Journal of Heart Failure",Supporting & Related Material,Background Material,2023-12-07T05:00:00Z,2023,12,,,2023-12-07T23:05:14Z,,0,0,090000648630c218
FDA-2023-N-3392-0033,FDA,FDA-2023-N-3392,"Reference 31 - Linehanm J., O. Harrison, S. Han, et al., “Non-Classical Immunity Controls Microbiota Impact on Skin Immunity and Tissue Repair,” Cell",Supporting & Related Material,Background Material,2023-12-07T05:00:00Z,2023,12,,,2023-12-07T23:12:22Z,,0,0,090000648630ca98
FDA-2023-N-3392-0001,FDA,FDA-2023-N-3392,"Medical Devices; General and Plastic Surgery Devices; Classification of Certain Solid Wound Dressings;
Wound Dressings Formulated as a Gel, Creams, or Ointment; and Liquid Wound Washes",Proposed Rule,Notice of Proposed Rulemaking (NPRM),2023-11-30T05:00:00Z,2023,11,2023-11-30T05:00:00Z,2024-02-29T04:59:59Z,2024-03-19T01:03:58Z,2023-26209,0,0,09000064862c31a9