Medical Devices; Gastroenterology-Urology Devices; Nonimplanted, Peripheral Electrical Continence Device
Information
Type
Rule
Regulated products
Medical Devices
Published
April 7, 2000
Last updated
April 7, 2000
Description
Document number 00-8596. The Food and Drug Administration (FDA) is classifying the nonimplanted, peripheral electrical continence device into class II (special controls). The special controls that will apply to this device are set forth below. The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976, the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997. The agency is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)