When Should a Reprocessor Place its Mark on a Device, Use a Detachable Label, or Use an Attachment?
According to section 502(u) of the Act, a reprocessed SUD, or an attachment to it, must prominently and conspicuously bear the name of the manufacturer of the reprocessed device, a generally recognized abbreviation of the name, or a unique and generally recognized symbol identifying such manufacturer. The only exception to this requirement is when the original device, or an attachment to it, does not prominently and conspicuously identify the name of the original equipment manufacturer, a generally recognized abbreviation of the name, or a unique and generally recognized symbol identifying such manufacturer. Under this circumstance, the reprocessor may use a detachable label on the packaging to identify the manufacturer of the reprocessed device. As stated in MDUFSA, the detachable label is intended to be affixed to the medical record of a patient. FDA therefore recommends that this label contain a statement directing a practitioner to remove the detachable label and affix it to the pa
