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U.S. Department of Health and Human Services

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FY 2009 MDUFA Performance Report Table of Contents

FDA continues to encourage meetings with regulated industry as an effective way to ensure that both FDA and applicants understand the clinical, scientific, and regulatory issues associated with new technologies. Pre-IDE, pre-PMA, device pre-IND, and device pre-BLA meetings have shown to be beneficial and are used routinely by industry. More formal types of meetings (agreement, determination, and 100-day meetings) are also available, but are not used as frequently by premarket applicants.

Next page: Quarterly Performance Reports