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  • Where did FDA 510 (K) form 3654 go? - The Elsmar Cove Quality Forum
    Thanks for the reply Also would like to ask for ISO 10993-11: Biological evaluation of medical devices — Part 11: Tests for systemic toxicity, as we have not conducted testing for the sub-chronic toxicity but we do have reports for systemic toxicity
  • Any experience on filling form, FDA 3654 for the DICOM standard?
    How have you handled filling out form 3654 for the DICOM standard? It's HUGE and we do not cover every modality and option But, we do adhere to the standard file format and rules How have you filled this out (and passed the submission) for the DICOM standard? Can I refer to our conformance
  • Filling Out FDA Form 3654 when Testing is Incomplete
    Question 3 on the 3654 is "was a third party laboratory responsible for testing conformity of the device to this standard identified in the 510(k)?" In my experience, if you answer "yes", the FDA expects a copy of the key elements of the lab's report, with their scope and design statement, conclusion and dated-signature pages, to be attached
  • How to use FDA Form 3654 - The Elsmar Cove Quality Forum
    You complete a copy of Form 3654 for each standard Use the three provided sections to state differing compliance conditions, parameters, etc for sections of a standard If more than three are needed, answer the same questions for additional ones on plain paper
  • 510(K) Cyber Security Documentation for Pre-market Submission (Templates)
    As per new rule along with other documents we need to submit Cybersecurity Documentation The type of documentation that we recommend you submit in your premarket submission is summarized in this section
  • Declarations of conformity and summary reports - The Elsmar Cove . . .
    Hello everyone, I am preparing my tradditional 510(k), until the 9th part for 510(k),I find the declarations of conformity requirement and in the guidance document,it says the declarations of conformity is for abbreviated 510(k)s So I want to know if I should submit declarations of conformity





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