Different Indications for Use in Different Countries -- how to handle IFU?

kchan

Starting to get Involved
#1
Apologies if this has been posted before! I could not find it.

We have a cleared device with Indications for Use, "X". We will soon receive a special 510(k) acceptance for an addition to our Indications for Use, "Y".

However, we are not cleared for use "Y" in other countries, and it will obviously take some time before we are cleared. How have other companies handled the Indications for Use in the IFU?

For example, can we write a general "Indications for Use" that contains X, and then below have a "USA Indications for Use" with both X and Y? Or must we have separate IFUs for all regions?

Thank you!
 
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chris1price

Trusted Information Resource
#2
When I managed a device with different indications, we had separate IFUs, and very clear massaging to differentiate the web-sites. That didn't stop FDA raising concerns when they reviewed the EU web-site by "mistake".
 
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