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CDRH fax policy: follow-up hard copies needed for data related to final reviews.

This article was originally published in The Gray Sheet

Executive Summary

CDRH FAX POLICY: FOLLOW-UP WITH "OVERNIGHT" HARD COPIES OF DATA will be required if the faxed information is "in whole or in part the basis for a final review decision" or "an administrative decision that may be treated as a final review decision," according to an internal memo recently circulated within the device center's Office of Device Evaluation. The memo states that sponsors "must follow the fax with a hard copy overnight to [the office's document mail center] to be logged in by the DMC as part of the administrative record prior to the issuance of the final decisions letter."

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