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Hello Everyone,
I finally was able to submit my 510(k) for my class II device to a third party reviewer about a month ago. I have since received their comments back about the deficiencies. Their main point was the biocompatibility of my device. My device is a very basic device that sits on a patient's head just like swimming goggles. They said that we have to make the complete set of molds and then assemble a production piece and then send it off for biocompatibility testing. I find this hard to believe because how do companies create full production injection molds if it has not been cleared? The material I am using is Dupont Hytrel 7246 which is a well-known material and has all the safety data attached.
My question is how do I approach this? Do I need to create the molds for everything and then create parts and then send them off for biocompatibility testing? Or do I just show them that it is the SOP's that it will be tested and be required to meet a certain standard when in full production?
Does anyone have experience with this? We are a very small startup company trying to make it in the medical device world but if we have to make molds and something needs to be changed it will put us out of business.
Thanks!!
I finally was able to submit my 510(k) for my class II device to a third party reviewer about a month ago. I have since received their comments back about the deficiencies. Their main point was the biocompatibility of my device. My device is a very basic device that sits on a patient's head just like swimming goggles. They said that we have to make the complete set of molds and then assemble a production piece and then send it off for biocompatibility testing. I find this hard to believe because how do companies create full production injection molds if it has not been cleared? The material I am using is Dupont Hytrel 7246 which is a well-known material and has all the safety data attached.
My question is how do I approach this? Do I need to create the molds for everything and then create parts and then send them off for biocompatibility testing? Or do I just show them that it is the SOP's that it will be tested and be required to meet a certain standard when in full production?
Does anyone have experience with this? We are a very small startup company trying to make it in the medical device world but if we have to make molds and something needs to be changed it will put us out of business.
Thanks!!