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CDRH Industry: FDA issues a Final Order to reclassify external pacemaker pulse generator (EPPG) devices

Today the FDA issued a final order to reclassify external pacemaker pulse generator (EPPG) devices.  An EPPG is a device used with cardiac pacing leads and temporarily worn outside of the body to regulate a patient’s heartbeat until a permanent pacemaker can be implanted. They are also used following heart surgery or after a heart attack to control irregular heartbeats. Under the final order, EPPG devices will be reclassified from   class III devices to class II (special controls).  This order also creates a new classification regulation for the pacing system analyzers (PSAs) and reclassifies the device into class II (special controls).

Under the new classifications, manufacturers of EPPG or PSA devices that are not currently on the market or for marketed devices that are about to be significantly changed or modified will need to submit a new 510(k).  Manufacturers with devices currently on the market must comply with the special controls outlined in the final order.

The FDA is issuing this final order as part of the 515 Program to ensure the appropriate regulation of Class III pre-amendments devices.

On Monday, when the final order officially publishes, it can be found by searching for docket number FDA-2011-N-0650 on www.regulations.gov.

Thank you,
Food and Drug Administration
Center for Devices and Radiological Health