Class III Medical Devices are devices that cannot be classified as Class I or Class II because:
# General and special control do not provide reasonable assurance of their safety and effectiveness
# The devices is to be used in supporting or sustaning human life and
# The device presents a potential unreasonable risk of illness or injury.
Class III devices typically require pre market approval (PMA). PMA application content includes:
# Full reports of all information, published or which should reasonably be known to the applicant, concerning investigations which have been made to show whether or not such device is safe and effective
# Full statement of the components, properties and principles of operation for the device
# Full description of the methods and the facilities used for the manufacturing, processing, packing and installation of the device
# Reference to any existing performance standards and adequate information to show that the device fully meets each standard
# Sample of the device or the location of one or moreĀ  devices readily available for examination and testing in the instance that the device is burdensome to move;
# The labeling proposed to be used for the device;
!Examples
Examples | of Class III devices are pacemakers, replacement heart valves and total joint replacements:
<<image /static/files/FDA/Example%20Class%20III.jpg width:600>>


See also: [[Premarket approval]]
bag
fda_public
created
Sat, 23 Jun 2012 13:50:16 GMT
creator
dirkjan
modified
Sat, 23 Jun 2012 13:50:16 GMT
modifier
dirkjan
tags
FDA
Term
creator
dirkjan