Information about Medical Device Reclassification
MedSun: Newsletter #65, October 2011
FDA Medical Devices Classification
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. If a determination is made to reclassify a device, FDA publishes a proposed rule to reclassify in the Federal Register which includes the scientific justification for reclassification and which affords a period for comment. Subsequently a final rule is published in the Federal Register which changes the reclassification.
FDA Medical Devices Classification. Reclassification. February 8, 2011.
Federal Register. Reclassification of the ECG Electrode. August 22, 2011.