General and plastic surgery devices; classification of silicone sheeting. Final rule.
The Food and Drug Administration (FDA) is classifying silicone sheeting intended for use in the management of closed hyperproliferative (hypertrophic and keloid) scars into class I (general controls). As a class I device, the device will be exempt from premarket notification requirements. This action is 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 (the SMDA), the Food and Drug Administration Modernization Act of 1997 (FDAMA), and the Medical Devices User Fee Modernization Act of 2002 (MDUFMA).
D001458:Bandages / Q000145:classification*; D017439:Cicatrix, Hypertrophic / Q000628:therapy; D004869:Equipment Safety; D006801:Humans; D007627:Keloid / Q000628:therapy; D011356:Product Labeling / Q000331:legislation & jurisprudence; D012828:Silicones / Q000145:classification; D013518:Surgery, Plastic / Q000145:classification / Q000295:instrumentation* / Q000331:legislation & jurisprudence; D014481:United States; D014486:United States Food and Drug Administration
D012828:Silicones