Remanufacturer

Under 21 CFR 820, remanufacturing is one of the activities that make a firm a manufacturer, with the quality system duties that follow. The line between remanufacturing and ordinary servicing depends on whether the change is significant, which FDA has addressed in separate guidance.

Remanufacturer means any person who processes, conditions, renovates, repackages, restores, or does any other act to a finished device that significantly changes the finished device's performance or safety specifications, or intended use. (b) All definitions in section 201 of the Federal Food, Drug, and Cosmetic Act shall apply to the regulation of quality management systems under this part and shall supersede the correlating terms and definitions in ISO 13485 (e.g., the definitions of device and labeling in section 201(h) and (m) of the Federal Food, Drug, and Cosmetic Act apply to this part and supersede the definitions for the correlating terms in ISO 13485 (labelling and medical device)). In addition, the following terms and definitions apply to this part and supersede the definitions for the correlating terms in ISO 13485 or ISO 9000: Implantable medical device shall have the meaning of “implant” as defined in section 860.3 of this chapter.

21 CFR, 820.3