CBE (Change Being Effected) 510(k) Submission

[monoj mon]

Recently we have added one "Contraindication" to our IFU of a previously 510(k) cleared device. The FDA guidance "Deciding When to Submit a 510(k) for a Change to an Existing Device" suggest (in the Figure 2, flowchart A, Point A2) to submit a "change being effected (CBE) 510(k)". However, after searching for a while, I have found a very little or no information on the content/structure of a CBE 510(k) notification. It is something new type of submission for us and any information regarding what should be the content of CBE 510(k) would be highly appreciated. Besides "Updated Labeling" what else should be submitted? Does this submission require the submitter to pay the MDUFA Fee?

 

[med_cert]

For each significant change you need to submit 510(k) Application before you implement this change to your device/system/labeling. Once FDA approves this change, you can modify your device/labeling. It is different for contraindication.
CBE refers to the basic 510(k) application only that prior to 510(k) submission you can state this new indication to your official labeling for US. The regular fee for 510(k) have to be paied. The content of CBE 510(k) should be the same as regular 510(k). You are allowed to mark chapters that are the same as in previous 510(k) submission.

 

[Ronen E]

Just a thought - if a new contraindication is now deemed necessary without any other change to the device, that would represent narrowing of the allowed/recommended use of existing devices that might be on the market / in the supply chain. I would think the Manufacturer would need to consider in such a case any safety aspects and take appropriate action to modify or collect devices with the old labeling (without the added contraindication) or to at least inform customers and users.