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U.S. Department of Health and Human Services

Medical Devices

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510(k) Additional Information Procedures #K93-1 (blue book memo) (Text Only)

FDA is withdrawing ODE Blue Book Memorandum K-93-1 “510(k) Additional Information Procedures.” FDA has reviewed the guidance document in light of recent changes to the law, including the user fee provisions of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), and believes the document is outdated. The document could result in the submission of unnecessary multiple premarket notifications (510(k)). Therefore, Blue Book Memorandum K-93-1 is rescinded and no longer in effect. Please see Blue Book Memo: Fax and E-mail Communication with Industry about Premarket Files Under Review A02-01, http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm149002.htm; or CDRH Device Advice, http://www.fda.gov/cdrh/devadvice/; or call the 510(k) Staff at (301) 594-1190, if you have any questions about additional information procedures for 510(k)s.