The U.S. FDA has wrapped up an October 2015 draft guidance for animal studies for medical devices, which prompted some lengthy responses from stakeholders concerned about some unique terms, such as device “handling.” Despite industrial opposition to the inclusion of that term, the final guidance retains the term handling and defines it in part as the manner in which the device “responds to the demands of the operator,” a term that may or may not be encompassed by the FDA’s overarching policy for human factors engineering.