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U.S. Department of Health and Human Services

Medical Devices

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Blue Book Memo: Fax & E-mail Communication with Industry about Premarket Files Under Review A02-01

The document entitled, “Blue Book Memo: Fax & E-mail Communication with Industry about Premarket Files Under Review A02-01” dated March 1, 2002 has been removed from FDA’s website to avoid discrepancies with a recent guidance document. More specifically, some of the information in the blue book memo has been superceded by a guidance document entitled, "Interactive Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements" dated December 28, 2007. We will visit the need for a supplemental guidance document in the future.