Medical Devices

Reclassification

As experience and knowledge about a device increase, the original classification can be adjusted via the process of reclassification. Changes in classification are based on FDA's receipt of new information about a device. FDA may, on its own, or in response to an outside petition, change a device's classification by regulation. A manufacturer who wishes to have a device reclassified to a lower class must convince FDA that the less stringent class requirements will be sufficient to provide reasonable assurance of safety and effectiveness.

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Page Last Updated: 09/09/2014
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