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Revised consensus standards

This article was originally published in The Gray Sheet

Executive Summary

CDRH will provide a transition period "on a case-by-case basis" during which both old and new versions of a standard will be recognized, according to a 11July 22 guidance. Declarations of conformity can still be accepted during the transition period, which will be included in the "supplemental information sheet" accompanying recognition of a standard. The guidance, superseding a June 2001 document, also clarifies that standards will become effective when their recognition is posted for pre-publication, and not merely on the date of the Federal Register notice...
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