This paper explores the possible paths of emergence of a new medical technology and how those paths might be altered by government regulations of the sort now promulgated by the Food and Drug Administration (FDA). The purpose of the paper is to help clarify the role of FDA regulation in a dynamic context. The analysis focuses on the idea that an emerging technology’s effectiveness may change over time and that the benefits and losses due to regulation may themselves have a dynamic character. An increasingly complex story of the emergence (or dissemination and development) process is told with the help of causal-loop diagrams. Results from a preliminary system dynamics model based on this story are illustrated and discussed. They suggest that the FDA’s actions may have unintended effects, such as slower   development of a technique, which may or may not be harmful. They also suggest that, in certain cases, post-marketing surveillance and communication of results may be at least as important an activity for the FDA as pre-marketing evaluation.

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Date created

• 1981

Type

• Document

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• Processing documentation available at: https://wiki.albany.edu/display/SCA/Processing+Ingested+Digital+Files

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• Creative Commons BY-NC-ND Attribution-NonCommercial-NoDerivs 4.0 International

  
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e8eac154b3129692f26c222dbc2c9466

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Part of

4a97153f59047c298f3bcd6b15c284f5

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23d738ba88f8333bc39725f9cb5bd0b8

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Collection

System Dynamic Society Records

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Collecting area

• This collection is part of the University Archives