Medical Devices; General and Plastic Surgery Devices; Classification of the Magnetic Surgical Instrument System
Information
Type
Rule
Regulated products
Medical Devices
Published
September 21, 2016
Last updated
September 21, 2016
Description
Document number 2016-22709. The Food and Drug Administration (FDA) is classifying the Magnetic Surgical Instrument System into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the magnetic surgical instrument system's classification. The Agency is classifying the 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)