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Medical Device Regulation Regulation

Special Controls Set By FDA For External Pacers, Analyzers

This article was originally published in The Gray Sheet

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Executive Summary

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.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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