I think the ADA's official position is to keep the government off. Most domestic labs, except for a few larger ones, also want no government involvment. My own calculations show between $10-15,000 dollars annually for compliance once the FDA ruling comes down. This includes filing fees with the FDA, DAMAS or ISO certifications, continuing records keeping, someone to fill out all the forms (often twice!), any necessary software and/or consultants, etc. It's about 500 PFMs to grind if we net $20 to $30 each!
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