To IDE or not to? FDA/CDRH website/guidance documents too hard to understand

T

txcn03

#1
#1
To IDE or not to?

Like many of the messages i have read, I to am finding it hard at times to get the information I need from the FDA/CDRH website/guidance documents. We are in the midst of helping a manufacturer of air filters. They are planning to attach a medical claim to their filter, therefore making it a medical device. The guidance documents focus on guidance for devices that are just entering the market, but what if the product is already on the market, but now it is just entering the device arena.

Is there anyone out there that can help clarify steps. I wanted to get an idea of the process before recommending to the people upstairs that an expert should be brought in.

Any help that anyone can give would be great. Beats muddling through piles of research and not finding any answers. Thanks in advance for the help!

txcn03
 
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Al Rosen

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#2
#2
Is there another air filter used in a similar application as a medical device? If so, it would only require what's referred to as a 510k. If you do not have Medical Device experience, you may want to consult with somebody who does. I don't think you want to discuss the details of your client's device and claims in an open forum.
 
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