Medical Device Safety and Efficacy Testing: Arrhythmia Monitors and Artificial Knees

摘要

This report is the first in a series of three commissioned by FDA to obtain baseline information on already-marketed medical device products. The other two reports studied the development processes for cutaneous blood oxygen monitors and digoxin diagnostic products and CPK-Isoenzyme Separation Test Kits, Transcutaneous Electrical Nerve Stimulators, Infusion Pumps, Endotracheal Tubes and Stress Testing Systems. 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 the extent of clinical evaluations; and patent status of the device.