When using consensus and/or voluntary standards in a 510(k), is it necessary to include a conformance matrix in the submission? If so, how detailed should it be? - Medical Devices Group

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Jackie Jaskula

Quality and regulatory through innovative solutions

October 2015

When using consensus and/or voluntary standards in a 510(k), is it necessary to include a conformance matrix in the submission? If so, how detailed should it be?

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source: https://www.linkedin.com/groups/2070960/2070960-6065525571830505474

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Posted by Jackie Jaskula

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 Report spam
	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. Marked as spam Report spam
	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... Marked as spam Report spam
	Private answer Jackie Jaskula Thanks to all! Marked as spam Report spam

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