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Submitting MR Compatibility Data for 510(k) Cleared Device

#1
I'm with a medical device manufacturer and we have several 510(k) cleared implants comprised of titanium. At the time that the 510(k) was submitted, we either did not discuss MR compatibility or went with the FDA's canned verbiage (this device has not been evaluated...). We have now conducted the testing and would like to incorporate the MR Conditional parameters into the IFU, which I can't do until I submit to the FDA. Special 510(k) guidance clearly says that this type of change requires a Traditional 510(k), but is it really necessary to complete an entire submission? Can I just say NA for every section except the MR compatibility section since no changes are made to the cleared device or do I really need to re-qualify all attributes of the device? Any experience with this type of submission is greatly appreciated.

Thanks,

Paul
 
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Ronen E

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#2
I think that N/A-ing most sections of a traditional is a risk.
If nothing else has changed, you can simply resubmit the same content from your past submission(s), and just update the relevant sections. You can (and probably should) state in your cover letter which parts have/haven't changed, to alert the reviewer.
 

primavesvera

Involved In Discussions
#3
I would go with the suggested approach as well. When we submitted a Special (there were more changes than 1), our reviewer reminded us that in the first submission we had submitted some additional documents (change of personnel and lack of information at the company) and that we need to resubmit them as well, even if there was no change.
 
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