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VOLUNTARY CONSENSUS STANDARDS AS "PRIMARY BASIS" FOR CLASS II 510(K) DECISIONS PROPOSED BY NEMA; CLASS III FIRMS OFFER LEGISLATIVE AGENDA

This article was originally published in The Gray Sheet

Executive Summary

Manufacturer certification with voluntary consensus standards would be the "primary basis" for determining safety and effectiveness for Class II devices under FDA reform legislation submitted to members of Congress the week of June 5 by the National Electrical Manufacturers Association.
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