The
Major Class Determination Factor Is The Risk The Device Poses To The Patient Or
The User.
Medical
device is classified in 03 categories- Class I (General controls), Class II
(General controls with special controls) and Class III (General controls,
Special Controls and premarket approval) devices.
Class I: This class of devices has the
lowest level of risks. Class I devices are not planned to help, support or
sustain life and may not present any irrational risks of illness or injury to
the user. Most of these devices do not need premarket notification and some
exempt to follow manufacturing practice regulation. –
Examples for class I: examination
gloves,bandages, hand-held surgical instrument,.
Class II: These devices are subject to
special controls, in additional to general control. Special controls are device
specific regulatory controls that ensure that the devices meet the intended
functionality. The devices for which general control alone cannot assure safety
and effectiveness, will require additive control similar to that of the
existing approved devices.
– Examples for class II: Pregnancy Kits, Acupuncture
Needles, Powered Wheelchairs, Infusion Pumps, And Surgical Drapes.
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