Biomedical Engineering Reference
In-Depth Information
what standards you would follow in obtaining the approval from the Italian
government.
11.8 How many sections are in ISO 10993? List the number and corresponding
title.
11.9 A new bioengineering company is interested in marketing a tissue-engineered
skin product. They hired you to help them in determining the standards neces-
sary for obtaining FDA approval. Provide three minimum standards they need
to begin working on the FDA approval process.
11.10 You have developed a new prosthetic device for the hand. List the steps you
would take to market this product in the United States, Europe, and Japan.
References
[1]
Offi ce of Human Research Protections, http://www.hhs.gov/ohrp/.
[2]
World Medical Association, http://www.wma.net/e/policy/.
[3]
National Commission for the Protection of Human Subjects of Biomedical and Behavioral
Research (NCPHSBBR),
The Belmont Report: Ethical Principles for the Protection of Hu-
man Subjects of Research
, 1979.
[4]
Beauchamp, T. L., and J. F. Childress,
Principles of Biomedical Ethics: Refl ections on a
Work in Progress,
5th ed., New York: Oxford University Press, 2001.
[5]
IEC 60601-1 subclause 2.2.1, 3rd. ed., 2005.
[6]
Federal Food and Drugs Act, Institutional Review Boards, Code of Federal Regulation Title
21 56.102, Defi nitions, Revised April 1, 2009.
[7]
Code of Federal Regulation, Title 21, Part 814, Volume 8, Premarket Approval of Medical
Devices, Revised April 1, 2009.
[8]
Code of Federal Regulation, Title 21, Part 11, Volume 1, Electronic Records: Electronic
Signature, Revised April 1, 2009.
Selected Bibliography
Bankert, E. A., and R. J. Amdur, (eds.),
Institutional Review Board: Management and Function,
2nd ed., Boston, MA: Jones & Bartlett, 2005.
Bulger, R. E., E. M. Bobby, and H. V. Fineberg, (eds.), “Committee on the Social and Ethical
Impacts of Developments in Biomedicine, Institute of Medicine,”
Society's Choices: Social and
Ethical Decision Making in Biomedicine
, Washington, D.C.: National Academies Press, 1995.
Engelhardt, Jr., H. T.,
The Foundations of Bioethics,
2nd ed., Oxford, U.K.: Oxford University
Press, 1995.
FDA, http://www.fda.gov/cdrh/devadvice/.
Hall, R.T.,
An Introduction to Healthcare Organizational Ethics,
Oxford, U.K.: Oxford Univer-
sity Press, 2000.
Hamer, D. H.,
The God Gene: How Faith Is Hardwired into Our Genes,
New York: Doubleday,
2004.
Kanholm, J.,
ISO 13485 and FDA QSR Internal Audit Checklist
, Milwaukee, WI: AQA Press
Publisher, 2005.
King, P. H., and R.C. Fries,
Design of Biomedical Devices and Systems,
2nd ed., Boca Raton, FL:
CRC Press, 2008.
