Device Recalls: A Study of Quality Problems

摘要

The document contains information on the causes of FDA medical device recalls for the period October 1983 through September 1988. Recommendations for establishing controls that can be used to minimize quality problems that lead to recalls are also included in the document. The information should be useful to medical device manufacturers in identifying those areas in which controls should be emphasized to prevent or minimize quality problems that lead to defective medical devices. It describes major problem areas and offers suggestions to industry regarding prevention and/or minimization of future quality problems. It also includes figures that graphically represent the data discussed; a list of figure titles is presented on the Contents page for easy reference.