Is there a counterpart to the General Safety and Performance Regulations for the USA?

#1
Hello,

i was wondering, if there is a counterpart to the GSPR (Annex I MDR 2017/745/EC) or the General Requirements (Annex I MDD 93/42/EEC) in the USA? In Europe there is with Annex I a very detailed list (23 Parts) about the safeness and performance requirements a medical device have to fulfill to get market access.

I would like to compare the list in Europe with the list in the USA if there is one, but I was not able to find it, anybody got a tip for me? Or are the requirements for medical devices only determined via the QSR CFR 820?

I thank you in advance for every clue,

thanks!
Paul
 
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#3
The EU has always taken a few-sizes-fit-all approach to medical devices. FDA has traditionally followed a model in which each device type is considered individually, thus all the classification regulations and product codes, which determine how each device type is regulated. Under the FDA model, the requirements are either defined by those already associated with a predicate device, or, if your device is novel, you must define them for yourself and then explain them to FDA. In the latter case, they should come out of your risk analysis. IMO.

I don't think FDA's controls are the equivalent of GSPR. FDA's controls are regulatory requirements, not safety and performance requirements. They are what FDA requires you to do in order for it to have confidence that your device will reliably meet its safety and performance requirements. The requirement to submit a 510(k) is a general control. It is neither a safety nor a performance requirement. Its purpose is to give FDA the opportunity to determine whether your device meets safety and performance requirements before it can be legally marketed in the US.

PS "Safety and performance" is the EU term. In the US, it is "safety and effectiveness," although perhaps honored as often in the breach as in the observance. Where the EU's "performance" means technical performance, they are different. Where it means clinical performance, they are at least very similar, and sometimes the same.
 
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