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U.S. Department of Health and Human Services

Medical Devices

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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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