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Hi,
Does any of you have suggestions on how to structure/design a regulatory gap analysis to move from the European market to US market for a medical device.
I realize that a 1:1 comparison is kind of impossible between the two systems and that my question is very broad, but maybe there is a common methodology to perform such a monstrous work in a structured and efficient way. For Europe I see several checklists of requirements, while for US I see only high level remarks on classification and pathways. Maybe there are also templates or checklists for USA I am not aware of and you may know.
Classification, regulatory pathway, and potential predicate in USA for my specific device have already been identified.
My idea so far is to analyze all the CFR title 21 and extract requirements for all the parts that from my point of view apply to medical devices and to my specific device. I am also planning to use the FDA guidances to help my interpretation of CFR.
Regarding "essential requirements" or "GSPR", I believe the correspondence in USA are the general controls + the special controls of my specific device. I am trying to address the special controls one by one identifying recognized standards from the FDA consensus database. I am also checking standards that our predicate used.
21CFR820 will be of course the source of my QMS upgrade. In addition requirements from the CFR parts will be used to update the regulatory requirements for the different processes, procedures, etc.
Do you think that this is the correct approach to proceed for such a broad regulatory analysis? Is there anything else I am missing, any other reference I should consider (e.g., FD&C act, Federal register?), or in general a better way to proceed? Also if you can provide any reference to a template or a checklist that can help even if only as a starting point, please let me know.
I believe that at this stage the risk of getting lost in regulations is pretty high, that's why I would benefit some hints from people that have already experienced something similar.
Thank you all