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I have some questions when i am reading the guidance document " deciding when to submit a 510(k) for a change to an exsiting device", especially the item B8.3, "Occasionally, however, either routine design validation activities produce unexpected results or otherwise prove to be inadequate to validate the design change.In such instances, questions of safety and effectiveness may be asociated with the design change, and the manufacturer may need to submit a new 510(k)".
Let's take the blood pressure monitor for example, if we made the change in software as well as the firmware, for example, the CPU is changed to achieve a quick response, or the PCB is changed to fit a new type of case housing, or a cheaper component replace the original one, that is, we fit the criteria of B8 of the guidance, the next step, we have to go to B8.1, B8.2, B8.3 of the flowchart for determination. Actually, i think we have to do the 60601-1 test and the 60601-1-2 test, the SP10 test, the software validation as the design validation. The question is, if the scheme of the design validation remains the same, and the results of the design change validation are as predicted, is a new 510(k) needed? Or document the efforts only is enough?
Is there anyone who can help me?
Thanks a lot
Let's take the blood pressure monitor for example, if we made the change in software as well as the firmware, for example, the CPU is changed to achieve a quick response, or the PCB is changed to fit a new type of case housing, or a cheaper component replace the original one, that is, we fit the criteria of B8 of the guidance, the next step, we have to go to B8.1, B8.2, B8.3 of the flowchart for determination. Actually, i think we have to do the 60601-1 test and the 60601-1-2 test, the SP10 test, the software validation as the design validation. The question is, if the scheme of the design validation remains the same, and the results of the design change validation are as predicted, is a new 510(k) needed? Or document the efforts only is enough?
Is there anyone who can help me?
Thanks a lot