Journal of Nanoparticle Research 13 (13):1401-1427 (2011)

W. John Koolage
Eastern Michigan University
Nanotechnology, as with many technologies before it, places a strain on existing legislation and poses a challenge to all administrative agencies tasked with regulating technology-based products. It is easy to see how statutory schemes become outdated, as our ability to understand and affect the world progresses. In this article, we address the regulatory problems that nanotechnology posses for the Food and Drug Administration’s (FDA) classification structure for ‘‘drugs’’ and ‘‘devices.’’ The last major modification to these terms was in 1976, with the enactment of the Medical Device Amendments. There are serious practical differences for a classification as a drug or device in terms of time to market and research. Drugs are classified, primarily, as acting by ‘‘chemical action.’’ We lay out some legal, philosophic, and scientific tools that serve to provide a useful, as well as legally and scientifically faithful, distinction between drugs and devices for the purpose of regulatory classification. These issues we raise are worth the consideration of anyone who is interested in the regulation of nano-products or other novel technologies.
Keywords Philosophy of science  Nanotechnology  Food and Drug Law
Categories (categorize this paper)
Edit this record
Mark as duplicate
Export citation
Find it on Scholar
Request removal from index
Revision history

Download options

PhilArchive copy

 PhilArchive page | Other versions
External links

Setup an account with your affiliations in order to access resources via your University's proxy server
Configure custom proxy (use this if your affiliation does not provide a proxy)
Through your library

References found in this work BETA

No references found.

Add more references

Citations of this work BETA

Add more citations

Similar books and articles

Nanotechnology, Sensors, and Rights to Privacy.Alan Rubel - 2010 - Public Affairs Quarterly 24 (2):131-153.
„Nanotechnologie“ AlS Neue „Schlüsseltechnologie“?—Versuch Eines Historischen Und Systematischen Vergleichs MIT Anderen Technologien.Andreas Woyke - 2007 - Journal for General Philosophy of Science / Zeitschrift für Allgemeine Wissenschaftstheorie 38 (2):329-345.
Nanotechnology: The Challenge of Regulating Known Unknowns.Robin Fretwell Wilson - 2006 - Journal of Law, Medicine and Ethics 34 (4):704-713.


Added to PP index

Total views
168 ( #68,664 of 2,498,211 )

Recent downloads (6 months)
14 ( #56,027 of 2,498,211 )

How can I increase my downloads?


My notes