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At a 1-day current regulatory topics session by ASQ held in Needham, MA, on June 16, 2005, Alan Kusinitz, Managing Partner of SoftwareCPR®, gave a presentation on the recent FDA Cybersecurity Guidance and the new revised FDA “Guidance for the Content of Premarket Submissions for Devices Containing Software.” A pdf of the slides used are at the link provided.
The portion on Cybersecurity includes a number of slides with content as directly presented by John Murray and Brian Fitzgerald of FDA at recent conferences in the US and London.
The portion on the new submission guidance highlights changes from the prior version and lists submission requirements by level of concern.