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I've created a web application and would like to market it. There are four pre-existing applications/devices and all of them are stand alone PC softwares. I have few questions I was wondering if someone can answer?
- Do I need a FDA 510K clearance for my web application?
- I have called around the companies that help with these applications but they ask around 20K, Does that sound reasonable?
- I don't have and can not afford 20K, can I submit the application myself?
- Any other alternatives?