PacoRabanez
Starting to get Involved
Hi to everyone.
I hope you all are well and fine.
I came across a particular topic and, I think, also widespread.
I searched over the forum but didn't find anything.
There is an equipment used to manufacture a medical device.
In particular, an arch welder to fabricate a dental titanium prosthesis.
Is this welder a medical device in the USA?
I cannot find anything across the FDA product code database or into their guidances.
My opinion is that a "simple" welder is not a medical device, but it is up to the manufacturer qualify and validate the process, the equipment and the related supplier.
So, the supplier have "no" responsabilities in term of USA regulation under FDA.
I would appreciate a lot if some of you experts could share any opinion (or material reference or experience too).
Thank you very much.
I hope you all are well and fine.
I came across a particular topic and, I think, also widespread.
I searched over the forum but didn't find anything.
There is an equipment used to manufacture a medical device.
In particular, an arch welder to fabricate a dental titanium prosthesis.
Is this welder a medical device in the USA?
I cannot find anything across the FDA product code database or into their guidances.
My opinion is that a "simple" welder is not a medical device, but it is up to the manufacturer qualify and validate the process, the equipment and the related supplier.
So, the supplier have "no" responsabilities in term of USA regulation under FDA.
I would appreciate a lot if some of you experts could share any opinion (or material reference or experience too).
Thank you very much.