The U.S. Food and Drug Administration (FDA) has issued draft guidance titled “Medical Device Reporting for Manufacturers.” Comments are requested on the draft, which is neither final nor in effect, by October 7, 2013. According to FDA, the guidance “describes and explains the current FDA regulation that addresses reporting and recordkeeping requirements applicable to manufacturers of medical devices for certain device-related adverse events.” Intended to update FDA policy and further clarify the agency’s interpretations of regulatory requirements, the document will supersede 1988 and 1997 versions when finalized.

Among other matters, the draft document defines certain terms, including what constitutes a reportable event, who is considered to be a manufacturer, when awareness of a reportable event occurs, and what constitutes a serious injury or malfunction. See Federal Register, July 9, 2013.