A new draft FDA guidance could make device companies vulnerable to off-label litigation by providing specific examples of when the government can charge them with a failure to have a new 510(k) for a modification to an existing device, and “criminalizing what has traditionally been considered a regulatory violation,” following a spate of agency losses on First Amendment grounds, suggest industry lawyers. Hyman, Phelps & McNamara's FDA Law Blog cited a history of FDA disputing companies' interpretation of when a...