FDA classification of devices

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