Biomedical Engineering Reference
In-Depth Information
2.9.1 Device Classification
The Food and Drug Administration (FDA) has classified all the medical devices
into three classes based-on the safety and effectiveness level [ 93 ]. The safety and
effectiveness levels are categorised in the low, medium and high risks, respectively.
Device classification determines different types of regulatory requirements that must
be followed by the medical device manufacturers.
Class I
Class I devices are sufficient to provide reasonable assurance of the safety and ef-
fectiveness of the device with minimal potential for harm. The devices of this class
are simpler than the Class II and Class III. These devices are subject to only general
controls. Manufacturer registration with the FDA, good manufacturing techniques,
branding and marking of the products are the main issues that are covered under
the general controls [ 93 ]. These general controls are sufficient to provide safety and
effectiveness of the devices. Class I devices are exempt from the premarket notifi-
cation and the FDA determines low risk of illness or injuries to patient [ 93 ]. Class I
devices include tongue depressors, bedpans, elastic bandages, examination gloves,
and hand held surgical instruments and other similar types of common equipment.
Class II
Class II devices more complex than Class I devices, and the general controls of
the Class II are insufficient to assure safety and effectiveness. To provide such as-
surances, additional methods are required [ 93 ]. Class II devices are also subject to
special control in addition to the general controls of Class I. Special controls may in-
clude standard performance, labelling requirements and premarket review to reduce
or mitigate risk. Class II assures that the used devices will not because of injuries
or harm to patients. X-ray machines, powered wheelchairs, infusion pump, surgi-
cal drapes, surgical needles, suture material and acupuncture needles are the main
devices of this class.
Class III
Class III devices have insufficient information to assure safety and effectiveness
solely through the general and special controls that are sufficient for Class I and
Class II devices [ 93 ]. In addition of the general controls of Class I, premarket ap-
proval and a scientific review are needed to ensure the safety and effectiveness of
the Class III devices. Class III devices are described as those for which “insufficient
information exists to determine that general controls are sufficient to provide reason-
able assurance of its safety and effectiveness or that application of special controls
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