Tag Archives: Class I devices

Devine Guidance

Class I Devices in the United States

By Dr. Christopher Joseph Devine

Although the regulatory burden is greatly reduced for Class I devices, manufacturers of Class I devices are still required to register their establishment with FDA, list their device(s) in the FURLS, and maintain general controls.

Although the regulatory burden is greatly reduced for Class I devices, manufacturers of Class I devices are still required to register their establishment with FDA, list their device(s) in the FURLS, and maintain general controls.

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