Federal regulations (created by the executive) are technically different from statutes (created by legislators), but there can certainly be criminal penalties for violating them. I wouldn&#x27;t be at all surprised if that were the case here, given the public safety implications of medical testing.<p>The letter says that Theranos must provide &quot;acceptable evidence of correction documenting that the immediate jeopardy has been removed&quot;. &quot;Has been&quot; is past tense, so Theranos really is required to fix the problems (at least the most serious ones) in ten days, not just plan to fix them.