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REVISED LASER 510(k) GUIDANCE ELIMINATES MANUFACTURER TRAINING POLICY

This article was originally published in The Gray Sheet

Executive Summary

REVISED LASER 510(k) GUIDANCE ELIMINATES MANUFACTURER TRAINING POLICY statement that was in an earlier draft of the document. The language was deleted from the most recent draft of the "Guidance on the Content and Organization of a Premarket Notification for a Medical Laser" because FDA wants to address issues related to manufacturer-sponsored device training in a general forum, rather than on a device-by-device basis.

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