Abstract
The Medical Device Amendments of 1976 (Public Law 94-295) consolidated and expanded existing federal authority over manufacturers of medical devices. This meant that any medical device manufactured after the Medical Device Amendment of 1976 needed to establish that it is substantially equivalent in terms of content, composition, intended use and related risk. This study was designed to investigate the influences on the process of notifying the Food and Drug Administration (FDA) of an orthopaedic medical device manufacturer's intent to market a product. The study's primary objectives were twofold: 1) determine the relationships of three independent variables (i.e., the company's size and longevity) with the dependent variable, time to equivalence and 2) compare differences in mean days to equivalence based on specified company characteristics (i.e., regulatory affairs consultant use, regulatory training experiences, in-house regulatory department presence or absence, and attitudes toward influences on timely compliance). A survey instrument was returned by the regulatory manager at 39 companies representing 263 device equivalence submissions and 27 different medical device categories from 1977 through 1987. Four different statistical approaches were utilized: correlative-regressive, comparative, regressive-predictive, and distributive. From this research certain company characteristics which impact time to equivalence were identified. It was found that companies who have been manufacturing numerous years, manufacture more than one medical device, and use regulatory affairs professionals to assist with compliance issues, especially just following the enactment of a new regulation, may have predictably fewer days to equivalence than companies that do not possess these characteristics. Statistically significant relationships and differences in mean days to equivalence were computed for some variables.
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