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Industry Encouraged By FDA Fulfillment Of MDUFA 2013 Goals

AdvaMed is pleased FDA met its review and performance goals for fiscal year 2013 as outlined in the October 2012 medical device user fee agreement.

The US Food and Drug Administration (FDA) surpassed its primary substantive interaction review goals for Premarket Approval (PMA) and 510(k) submissions in fiscal year 2013, according to its annual report on medical device user fee agreement (MDUFA III) performance data.

Under the user-fee agreement, FDA committed to substantive interaction (SI) goals, the time by which it must meet with the sponsor after an initial review, and final decision goals. (See...

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