Physical Medicine Devices; Revision of the Identification of the Ionotophoresis Device
Information
Type
Proposed Rule
Regulated products
Medical Devices
Published
August 22, 2000
Last updated
August 22, 2000
Description
Document number 00-21251. The Food and Drug Administration (FDA) is proposing to amend the physical medicine devices regulations to remove the class III (premarket approval) iontophoresis device identification. FDA is taking this action because the agency believes that there were no preamendments iontophoresis devices marketed for uses other than those described in the class II identification. 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 FDA Modernization Act of 1997.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)