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

This article was originally published in The Gray Sheet

Executive Summary

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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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.

513(g) Device Classification Requests Drop; FDA Plans Guidance

FDA's device center has seen a big drop-off in 513(g) requests since a new user fee put a hefty price tag on the voluntary product classification queries

Device Classification Request Filings Often Unnecessary, Says FDA Official

Companies should think twice before filing a 513(g) request, given that the formal information queries are now subject to user fees and often could be answered by a simple phone call to FDA, says an agency official

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