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U.S. Department of Health and Human Services

Medical Devices

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MDUFMA Guidance Documents

New Guidance

FY 2013 Medical Device Small Business Qualification and Certification

FY 2012 Medical Device Small Business Qualification and Certification

Interactive Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements - Describes the roles of both FDA and industry in an interactive review process of specific medical device submission types.

 

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