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
fda-device · Food and Drug Administration · Rule · Published 1999-10-05 · Effective 1999-11-04 · 64 FR 53927
Document
Document number
99-25791
Federal Register citation
64 FR 53927
CFR reference
21 CFR 878
Type
Rule
Action
Final rule.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
1999-10-05
Effective date
1999-11-04
HHS docket
Docket No. 78N-2646
Abstract
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).