Do we have to submit a new 510(k) for a device with a new MCU?

M

MIREGMGR

#11
I have just got a FDA's response about this question.

You may only market one version or model of the subject device under the current 510(k) clearance. You may market the "old device" using the existing 510(k) clearance and the "new or modified device" using a separate FDA clearance.
It probably should be noted that this response is dependent on a particular context. If for instance the original 510(k) filing had been for more than one product version, or a family of related, functionally similar products, then my understanding is that it would be be permissible to continue to market multiple versions.
 
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W

wangyang

#12
It probably should be noted that this response is dependent on a particular context. If for instance the original 510(k) filing had been for more than one product version, or a family of related, functionally similar products, then my understanding is that it would be be permissible to continue to market multiple versions.
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Thank you MIREGMGR. Sometimes it is very hard to include all version of the product in one 510(k), because new version appears usually after the old version's 510(k) is cleared. Maybe new 510(k) sumission is the only way to market the new version of the product.

By the way, Is there anybody who have the experience of submit the product series in one 510(k)?

I have searched the 510(k) database, and found a interesting 510(k) summary( please refer to the attachment).

In this 510(k), all supporting material(like the electrical safety test report and the EMC test) should be provided for every product in this series(like BPM123,BPM145,BPM143...)? That is a big task, isn't it?
 

Attachments

W

wangyang

#13
Moreover, in item 2.0 of the attachment, it says that ( The monior change meaning device change that do not affect the conformity test result of EMC&Safety), what does it mean by? I guess it means that the change may rise the new test of safety and EMC, but if the result is" pass", then this change is a "minor change", What do you think? English is not my native language.


Thank you.
 
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