Marketing a single medical device with multiple indications

[funkgirl]

Hi! I have a single medical device that has 510(k) clearance for 2 different indications, thus 2 different ProCodes.

The instructions for use are primarily the same (just a few minor differences), as well as warnings/precautions.

My team wants to market this as a single device that can be used for either cleared indicated purpose. I can't find any reason NOT to approve this pathway, but curious if anyone has a similar device and can offer insight.

Thanks!

Tina

 

[JeantheBigone]

If it's cleared for both indications, I'm curious what would potentially stand in the way of marketing it for both? It sounds as if you're in the clear as far as the regs go.

 

[funkgirl]

We want to sell it as a single product that can be used for either indication - with single IFU containing precautions and instructions for both indications.

 

[nvquality]

Hi,

So the device was cleared using two separate IFUs? The second 510(k) didn’t include the indications of the first 510(k)?

If changes were made to the device for the second 510(k), you need to confirm that the device is in fact still cleared for the first indication. Assuming no significant changes were made (so the device is still cleared for all claimed indications), and especially if the warnings are the same or similar, I haven’t run into any issues combining multiple IFUs. I have had this situation a number of times and had no problems result from using this approach.

It sounds like the indications and warnings might be close enough not to be an issue, but you might want to do a quick risk assessment to make sure the resulting IFU isn’t confusing, that everything is clear for each use.

 

[funkgirl]

Great - thanks for the feedback! To confirm, there are zero changes to the device - it's the exact same device with indications for both topical and implantable use to achieve the same therapeutic purpose.