Special Controls Set By FDA For External Pacers, Analyzers

18 Apr 2016

A final order from the agency places external pacemaker pulse generators in class II, and also puts pacing system analyzers into a separate class II category – including triple-chamber analyzers, which was previously been regulated as class III PMA devices. All new language or significantly modified products in the categories will be subject to 510(k)s.

FDA has now settled external pacemaker pulse generators and pacing system analyzers into distinct class II with special controls risk categories. The agency issued a final order

on April 18 that takes immediate effect.