General and Plastic Surgery Devices; Classification of Silicone Sheeting
fda-device · Food and Drug Administration · Rule · Published 2004-08-09 · Effective 2004-09-08 · 69 FR 48146
Document
Document number
04-18074
Federal Register citation
69 FR 48146
CFR reference
21 CFR 878
Type
Rule
Action
Final rule.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2004-08-09
Effective date
2004-09-08
HHS docket
Docket No. 2002N-0500
Abstract
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).