Medical Device Reference File. Plastics: Blood and Solution Filters

摘要

The Medical Device Reference File (MDRF) provides information on the production and quality control of medical devices which are of particular interest to FDA. There are several volumes of the MDRF, with each one having information on a specific product, i.e., this volume discusses production of blood and solution filters. All volumes are organized in the same way: an introductory chapter; two chapters which describe the product's use, classification, and an overview of production; a final chapter on complaints; and six core chapters that describe in more detail product production including: Receive and test material/components; Manufacture/assemble product; Final test product; Package and label product; Sterilize product; Warehouse and distribute product. The format of each core chapter is also standardized throughout each volume of the MDRF to include a summary, flowchart, process chart, and GMP considerations.