The United States Food and Drug Administration (FDA) recently issued Draft Guidance for Industry entitled “Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C” (the Draft Guidance). 1/ As FDA Associate Commissioner for Regulatory Affairs Melinda K. Plaisier explained, part of FDA’s work is “keenly focused on guiding companies on steps needed to ready their facilities and staff for possible recall situations.” The Draft Guidance is the latest step in the Agency’s efforts over the past 18 months to proactively and systematically update the FDA recall process.