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  • We are getting pretty far off the topic of modification to a 510(k). I think I will take this up again when I'm ready to post more of my analysis of the post-guidance De novos. ------------------------------ Julie Omohundro, ex-RAC (US, GS), still an MBA Principal Consultant Class Three, LLC Durham, North Carolina, USA 919-544-3366 (T) 434-964-1614...

  • Julie, you're right in that the De Novo petition is not the same as 510(k), but it is more similar to a 510(k) submission than any other submission, and in a sense it's an extension of the 510(k). Most of the content from a 510(k) submission applies to the De Novo, especially if it contained the clinical data. The process is not so much different...

  • Thank you Julie for reiterating that important distinction. In case folks missed my post from a couple days ago, section 513(f)(2) of the Act is the section to which Julie is referring and that provides for the "de novo" reclassification process. ------------------------------ Kevin Randall, ASQ CQA, RAC (U.S., Canada, Europe) Principal Consultant...

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