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Please note: as of October 1, 2002, FDA charges fees for review of Premarket Notification 510(k)s and Premarket Approvals
Class I devices are subject to the least regulatory control. They present minimal
potential for harm to the user and are often simpler in design than Class II or Class III
devices. Class I devices are subject to "General Controls" as are Class II and
Class III devices.
General controls include:
Examples of Class I devices include elastic bandages, examination
gloves, and hand-held surgical instruments.
Most Class I devices are exempt from the premarket notification
and/or good manufacturing practices regulation. Information on Class I exempt
devices is located under the heading What are Class I/II
Exemptions?.
Class II devices are those for which general controls alone are insufficient to assure safety and effectiveness, and existing methods are available to provide such assurances. In addition to complying with general controls, Class II devices are also subject to special controls.
A few Class II devices are exempt from the premarket notification. Information on Class
II exempt devices is located under the heading What are Class
I/II Exemptions?
Special controls may include special labeling requirements, mandatory
performance standards and postmarket surveillance.
Examples of Class II devices include powered wheelchairs, infusion
pumps, and surgical drapes.
Device Classification Panels
Class III is the most stringent regulatory category for devices. Class III devices are
those for which insufficient information exists to assure safety and effectiveness solely
through general or special controls.
Class III devices are usually those that support or sustain human life, are of
substantial importance in preventing impairment of human health, or which present a
potential, unreasonable risk of illness or injury.
Premarket approval is the required process of scientific review to ensure the safety
and effectiveness of Class III devices. Not all Class III devices require an approved
premarket approval application to be marketed. Class III devices which are equivalent to
devices legally marketed before May 28, 1976 may be marketed through the premarket
notification [510(k)] process until FDA has published a requirement for manufacturers of
that generic type of device to submit premarket approval data.
Class III devices which require an approved premarket approval application to be marketed are those:
Examples of Class III devices which require a premarket approval include replacement
heart valves, silicone gel-filled breast implants, and implanted cerebella stimulators.
Class III devices which can be marketed with a premarket notification 510(k) are those:
Examples of Class III devices which currently require a premarket
notification include implantable pacemaker pulse generators and endosseous implants.
Device Classification Panels
Updated November 21, 2002
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