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. Food and Drug Administration, HHS. Final rule.
The Food and Drug Administration (FDA) is classifying the nonresorbable gauze/sponge for external use, the hydrophilic wound dressing, the occlusive wound dressing, and the hydrogel wound dressing into class I (general controls). FDA is also exempting these devices from premarket notification procedures. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (SMDA), and the Food and Drug Administration Modernization Act of 1997 (FDAMA).
D001458:Bandages / Q000145:classification*; D006801:Humans; D020100:Hydrogels / Q000145:classification*; D007883:Legislation, Medical; D009779:Occlusive Dressings / Q000145:classification*; D015503:Surgical Sponges / Q000145:classification*; D014481:United States; D014486:United States Food and Drug Administration
D020100:Hydrogels