To my knowledge, there is no "general" guidance on what devices or parts of devices, need to be radio-opaque. That said, I do not claim to have read every specific guidance for types of implantable devices, so there could be some product type specific requirements.
That said, I do have experience with many implantable devices, both PMA and 510(k). Generally the decision to use radio-opaque material in/on the device was driven by our risk analysis. If there was a risk that could be mitigated by being able to image the device, we tended to include it. If there wasn't, or if another way of mitigating it was available, we did not. So, for instance, when a revision surgery might be necessary but the component would be deeply buried and hard to see, we made them visible for imaging as it mitigated risk of leaving something behind. For other implants we did not. I also think in a few cases we probably erred in not making them easy to image.
As you say, complete biocompatibility requirements apply to any materials introduced to make the product radio-opaque.
g-
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Ginger Glaser RAC
Vice-President, Quality and Regulatory Affairs
Maplewood MN
United States
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Original Message:
Sent: 25-Jan-2017 09:41
From: Edenia Guevara
Subject: Implantable devices: Radio Opaque Marking
Dear all:
I would like to know your experience with implantable devices. We are currently working in R&D of a product that has been under investigation for almost 2 decades. We are very close to launch this product to the market.
This implantable device has several implantable electronic modules, one of the modules (the main one) is called P.Module, the other ones (smaller ones) are called R.modules. We are thinking (but we don't know) if need to mark ALL these modules by using radio opaque so in case of an emergency, devices can be identified by X-Ray .
We are wondering if we need to radio opaque our implantable device. If there any guidance that clarifies which implantable devices need to be market? Is there any specific requirement that I need to take in account for Radio Opaque? e.g. the material being added must be Biocompatible.
Thank you very much for your help!!
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Edenia
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