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
Thanks,
Paul