“Thus, a company’s failure to document its decision-making cannot be used to solely support a civil enforcement action against a company for failing to submit a new 510(k).”
“Arbitrary and Unpredictable” Enforcement Action
Ethan Davis, the soon-to-be former Deputy Assistant Attorney General for the Consumer Protection Branch (CPB), is leaving DOJ to clerk for Supreme Court Justice Neil Gorsuch. In a recent speech, according to the blog, Davis described the basic tenet that “[i]n our system, law is made by statute, and regulations are made by notice and comment rulemaking. Neither should be made by guidance documents.” And Davis renewed the commitment by DOJ CPB to “create an enforcement environment premised on the rule of law, so that you as regulated entities do not feel subjected to arbitrary and unpredictable enforcement actions.”
Walsh concludes that only time will tell whether these DOJ principles are followed in future enforcement actions, “but it behooves companies to remind DOJ of these stated principles if prosecution appears not grounded in law and only in guidance.”
