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source: https://www.linkedin.com/groups/2070960/2070960-6065525571830505474 Marked as spam
 Posted by Asked on October 29, 2015 12:00 am
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Private answer
Anthony Piotrkowski, RAC, CQA
there is guidance for this on FDA website (see link below). If you use FDA 3654, it walks you through the process and gives you an idea of the kind of detail to include.
http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm077295.pdf Marked as spam
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Private answer
Rob Packard
You are only required to include the recognized standards. Some reviewers only expect you to complete the Form 3654 for the standards that you tested your device against. Other reviewers are a little more picky. Occasionally they will request that you complete a Form 3654 even if the standard is only mentioned in a report.
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Private answer
Robert van Boxtel
FDA is currently looking into obsoleting this form, as stated by FDA 510k process representatives during the last AdvaMed training. The added value of this form in it's current form is questioned also by them. But keep using it now...
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