Projecting the impact of the 1976 Medical Device Amendments on innovation in clinical chemistry tests

This paper is concerned with the impact of the Medical Device Amendments of 1976 and its implications in terms of innovation. With this objective the paper first describes the Medical Device Amendments of 1976. The paper then reports empirical evidence on the sources of a subset of innovations regulated by the Amendment's clinical chemistry diagnostic products. Finally, based on the pattern of innovations found, some thoughts are expressed about the likely effects of the Amendments.