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Really need some feedback on this one...
My question is in regards to FDA Memorandum #k97-1 "Deciding When to Submit a 510(k) for a Change to an Existing Device". Para. B8.3 of the document (and the attendant flowchart) creates a decision box asking: "Do results of design validation raise new issues of safety and effectiveness?". If the response is "YES", a new 510(k) is required. If "NO", documentation is adequate.
We have a cleared Class II device which we are modifying in a way that creates new risks. These risks are being assessed through our Risk Management process and were determined to be of an acceptable level per our procedure. Nonetheless, they are new risks.
My specific question: Does the creation of a new risk equate to being a "new issue of safety...." as per the memorandum definition? And if so, does that fact that the new risk is acceptably mitigatible "trump" the "YES" path of this particular decision.
As always, I am fully aware that a "guidance" document is just that. Nevertheless, I'd appreciate any feedback from "real" user experience!
My question is in regards to FDA Memorandum #k97-1 "Deciding When to Submit a 510(k) for a Change to an Existing Device". Para. B8.3 of the document (and the attendant flowchart) creates a decision box asking: "Do results of design validation raise new issues of safety and effectiveness?". If the response is "YES", a new 510(k) is required. If "NO", documentation is adequate.
We have a cleared Class II device which we are modifying in a way that creates new risks. These risks are being assessed through our Risk Management process and were determined to be of an acceptable level per our procedure. Nonetheless, they are new risks.
My specific question: Does the creation of a new risk equate to being a "new issue of safety...." as per the memorandum definition? And if so, does that fact that the new risk is acceptably mitigatible "trump" the "YES" path of this particular decision.
As always, I am fully aware that a "guidance" document is just that. Nevertheless, I'd appreciate any feedback from "real" user experience!