[Weelok]

In my experience in working with certifications, which are electrical and NOT FDA, there is generally very little cost from a government fee side but an enormous cost in submitting answers to questions or in supplying test data or compliance information. Typically the cost is in labor hours, consultants that are knowledgeable in the ways of the certifying agency, and in perhaps testing your product at a certified lab or some such.

For example, FCC compliance means you have to test your product at a lab and supply an official test report demonstrating compliance. This could be your lab or one you contract with. This cost then is your cost to comply.

So when the FDA states the cost to comply is $XXX it's generally not the real cost.

Does this match what the articles are stating or claiming?