FDA classification of devices


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Related to FDA classification of devices: CDRH

FDA classification of devices

A system of stratifying devices used for various health care needs based on the potential for causing morbidity
FDA classification, medical devices
I  Devices used by and easily accessible to the public; regarded as having minimal potential for incorrect use when used in health care
II  Must undergo an approval process that includes special controls, eg performance standards and general controls required of all devices
III In addition to the above, the device or product must meet a rigorous premarketing approval standard, which may delay the release of the product by months or years