Medical Device Safety and Efficacy Testing Case Studies: CPK-Isoenzyme Separation Test Kits, Transcutaneous Electrical Nerve Stimulators, Infusion Pumps, Endotracheal Tubes, Stress Testing Systems

摘要

This report is the third in a series of three commissioned by FDA to obtain baseline information on already-marketed medical device products. The two earlier studies examined the development processes for arrythmia monitor devices, artificial knees, cutaneous blood oxygen monitors, and digoxin diagnostic products. Telephone contacts and at least one site visit provided the material for case studies of three manufacturers for each device. The objective of the case studies was to describe the specific steps taken to bring each product to market. Each product selected was brought to the market prior to the enactment of the Medical Device amendments in 1976. Thus, the case studies capture what specific companies did before FDA regulation. In particular, descriptions, and in many cases, data were gathered on: size and history of company; product development process; investment in the product, both labor and dollars; nature of and extent of clinical evaluations; and patent status of the device.