General Hospital and Personal Use Devices; Classification of Liquid Chemical Sterilants/High Level Disinfectants and General Purpose Disinfectants
Information
Type
Rule
Regulated products
Medical Devices
Published
June 8, 2000
Last updated
June 8, 2000
Description
Document number 00-14462. The Food and Drug Administration (FDA) is classifying liquid chemical sterilants/high level disinfectants intended for use as the terminal step in processing critical and semicritical medical devices prior to patient use into class II (special controls), and general purpose disinfectants intended to process noncritical medical devices and equipment surfaces into class I (general controls). FDA is also exempting the general purpose disinfectants from the premarket notification requirements. 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 (the SMDA), and the Food and Drug Administration Modernization Act of 1997 (the FDAMA).
Tags
Organization
Country / Region
United States
License
Other (Public Domain)