I heard this was about $500k in additional cost and maybe +6mo, starting from a reasonable technical basis, which doesn't seem that bad.
There's also the "sell it outside the USA, then sell inside the USA" model.
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I don't think this is true. The initial certification is ~$28k and the auditors just watch you demonstrate the list of criteria. Sure, there are interoperability requirements (and other requirements such as drug interactions) that may take some time to implement, but all of these requirements are simply features that many of your competitors have anyway.