Good morning Paul,
I work with a group that is developing a MR-compatible device and we also do MRI-compatibility testing. Below is my intake on the issues.
1- In regards to regulation: The industry standard for MR compatibility is ASTM F-2503-05, F-2119, F 2282, and F2213. These standards should provide important information in regards to MR compatibility testing.
2- Paper work: In regards to how much paper work and if it whether or not it requires a new 510(K), it depends on how your device is used (intented use) and safety. I attended a meeting with the FDA about using an approved non-MR compatible in the MR room and the main issue for the Agency was that the new environment constituted a new indication. However, we focused on the fact that the device was not going to be changed and it was most likely a change on labeling only.
3- 1.5T or 3T? It is something that your engineers need to decide as these scanners can be quite different in terms of magnetically induced force, unintended heating, and imaging artifact. To be labeled as "MR Safe", the device should not pose any known hazards in
ALL MR environments. So, if you have yet to start testing, it is worth evaluate how much it would cost to make the device "MR Safe", rather than "MR Conditional".
Best of luck in your project. Let me know if there is anything else I could assist you with.
Valeria
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Valeria Sena-Weltin RAC
Sr. Regulatory Affairs Associate
Baltimore MD
United States
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Original Message:
Sent: 04-10-2014 08:25
From: Paul Vagts
Subject: MR Compatibility
We are looking to conduct some MR testing of our titanium implants to determine the MR Conditional parameters for labeling. Should 1.5 Tesla or 3 Tesla be evaluated? Is there an industry standard on this? As a follow-up question, if this were to be added to the labeling of existing devices is that something that needs to be addressed in a 510(k) or is internal documentation sufficient to justify this change? Based on the FDA guidance document, "Deciding When to Submit ...", I am inclined to view this as a labeling change intended to be a "change in warnings and precautions" or the "labeling being revised for clarity to insure safer or more effective use". In either case, flowchart A leads to documentation. I have heard others claim this is a change to the intended use and therefore requires a traditional 510(k), but that seems excessive to me. Any thoughts or feedback?
Thanks a bunch!
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Paul Vagts
Parcus Medical
Sarasota FL
United States
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