Regulatory Focus™ > News Articles > US Regulators Reclassify Pacemaker Electrodes as Higher-Risk Devices

US Regulators Reclassify Pacemaker Electrodes as Higher-Risk Devices

Posted 06 July 2012 | By

After a series of problems in which permanent pacemaker electrodes have been associated with adverse events, the US Food and Drug Administration (FDA) said it will reclassify the electrodes as Class III medical devices. As a result of the reclassification, manufacturers of permanent pacemaker electrodes will now be required to submit either a premarket approval application (PMA) or complete a product development protocol (PDP) in order to legally market a permanent pacemaker electrode.

In a Federal Register posting on 6 July, FDA said it was instituting the changes to enhance the devices' safety profile "by requiring the device to meet the statute's approval requirements."

The agency had first proposed the classification of the devices in August 2011, but received no comments regarding the reclassification.

The devices have been in use since before the 1976 Medical Device Amendments (MDA), which previously allowed them to be introduced into interstate commerce through clearance of FDA's 510(k) substantial equivalence pathway or pre-1976 approval from FDA. Under the 5 July final rule, FDA will require all such devices to be approved or cleared through a PMA or PDP process.

The rule will go into effect 90 days after 6 July 2012.


Read more:

FDA - Effective Date of Requirement for Premarket Approval for Cardiovascular Permanent Pacemaker Electrode


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