ARRHYTHMIA MONITOR DIAGNOSTIC CAPACITY IS PRIMARY DOWNCLASSIFICATION FACTOR, FDA SAYS; HIMA DRAFT PETITION PROPOSES CLASS II FOR ALL ARRHYTHMIA MONITORS
This article was originally published in The Gray Sheet
Executive Summary
Arrhythmia monitors' diagnostic capacity will be a primary consideration for FDA in deciding which types of the preamendments Class III devices are eligible for downclassification, the agency says.
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