FDA-registration and inspection cost

#1
Hi there,

I'm with a company that's about to register as manufacturer for a medical device. (We are not the company who lists the product)

There is, of course a fee, associated with this. About 5000 USD per year.

Who covers the cost for FDA-inspections? I assume this is not included in the yearly registration fee.

Appreciate some input on this! Thanks!
 
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