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Industry effects of medical device regulation: The case of diagnostic imaging equipment
Author(s) -
McKay Niccie L.
Publication year - 1986
Publication title -
journal of policy analysis and management
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.898
H-Index - 84
eISSN - 1520-6688
pISSN - 0276-8739
DOI - 10.1002/pam.4050060104
Subject(s) - legislation , medical device , competition (biology) , business , government regulation , industrial organization , product (mathematics) , medical equipment , environmental regulation , risk analysis (engineering) , marketing , public economics , economics , medicine , law , political science , ecology , geometry , mathematics , nursing , china , biomedical engineering , biology
In 1976 Congress passed legislation authorizing the regulation of all medical devices. Some observers predicted that this regulation would have adverse effects on the newly regulated industries. This paper examines the major features of the medical device regulatory program and investigates how the regulation has affected the diagnostic imaging equipment industry. The results indicate that medical device regulation has not materially affected competition or innovation within established product classes in this industry. This suggests that, by choosing methods of regulation that differentiate among levels of potential risk to consumers, the goal of consumer protection can be achieved with fewer undesirable effects on the regulated industry.