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Regulatory News In Brief

This article was originally published in The Gray Sheet

Executive Summary

FDA issues final guidances on 513(g) requests for information on device classifications. Panel to meet June 13 on expanded indication for Sapien transcatheter valve. More FDA news.

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FDA Releases Draft Guidelines On 513(g) Device Classification Requests

FDA released two draft guidances April 29 to help firms better understand the agency's 513(g) device classification request program - and when the costly voluntary filings are unnecessary





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