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Simplified warning letters for premarket violations by smaller firms to be implemented by FDA.

This article was originally published in The Gray Sheet

Executive Summary

SIMPLIFIED DEVICE WARNING LETTER LANGUAGE FOR SMALLER COMPANIES violating premarket requirements is expected to be implemented by FDA in the coming weeks, agency staffers say. The revised format is targeted to small start-up firms that are marketing a device without prior FDA review. The letters would spell out alleged deficiencies and legal requirements in layman's terms, and are intended to help firms that may be unfamiliar with the rules.
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