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FDA Proposes Class II Status For External Pacemaker Pulse Generators, Analyzers

External pacemaker pulse generators and pacing system analyzers would move from class III to class II with special controls in a Sept. 15 proposed order. For most of the products, the 510(k) route would be maintained, but triple-chamber PSAs would move from PMA to 510(k) review under the proposal. .

FDA describes special controls to mitigate risks of external pacemaker pulse generators and pacing system analyzers in a proposed order downclassifying the two products from class III to class II, issued on Sept. 15. The agency on the same day withdrew an October 2011 draft special controls guidance document and proposal classification rule for the EPPG devices. (See Also see "Class Act: Status Of CDRH’s 515 Initiative" - Medtech Insight, 19 August, 2013..)

The new proposed order aligns with the 2011 proposed rule in electing to reclassify the preamendment EPPG devices from class III to II, and maintaining the 510(k) premarket route for...

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