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U.S. Department of Health and Human Services

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In Vitro Diagnostics

FY 2009 MDUFA Performance Report Table of Contents

Under the HHS Commitment Letter, FDA is studying and pursuing a variety of approaches to clarify its regulatory requirements and reduce regulatory burdens. As part of this effort, FDA published three new guidance documents specifically called for in the HHS Commitment Letter:

Next page: Appendix A: September 27, 2007, Commitment Letter from HHS Secretary to Congress