HISTORY OF MEDICAL DEVICE REGULATION
A unique government, industry, and health care community / consumer initiative, which began in 1970, produced the Medical Device Amendments of 1976. The initial implementation of these 1976 Amendments was considered successful because of a multi-partisan effort put forth to assure the reasonable and flexible application of law to the best interest of public health. During the decade of the 1980's, however, the medical device industry became the object of increased Congressional and media interest. Much of this interest was critical of the efforts of the FDA and industry.
The near absence of an industry defense coupled with a remarkable lack of positive industry representation supported a hostile environment. This led to a more oppressive regulatory posture in which the FDA emphasized enforcement at the expense of its new product clearance activities. The agency's enforcement mentality impacted severely on the industry, and the effects were exacerbated by the enactment of additional restrictive device amendments to the Federal Food, Drug, and Cosmetic Act in 1990 and 1992. The situation soon evolved into a product clearance crisis that choked emerging new technologies and triggered an exodus of medical device companies from the United States.
The MDMA was created in 1992 to help reverse this trend of over-regulation of the device industry through initiatives at the grassroots and national levels. Acting as the Washington eyes, ears, and voice of its members, MDMA stands as a watchdog against any such unreasonable regulation in the future and to represent the interests of medical device manufacturers and their customers-the American public.