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  • Print publication year: 2011
  • Online publication date: June 2012

12 - Regulatory affairs and testing

from Part III - Case studies

Summary

A medical device company is developing a material for use in vascular grafts. What should the designers keep in mind from a regulatory standpoint as they move toward developing a prototype implant?

The regulatory aspects of medical device approval can be the least familiar part of the medical device development process, particularly for engineers and scientists. It can be very useful to think ahead to what types of tests will be instrumental in gaining approval from the Food and Drug Administration (FDA). This company will want to decide if it is planning to market the device itself, or merely supply the material to another company that will be the primary distributor of the implant. Second, the company might want to check the FDA database to see what guidance the FDA may provide for these implants. Third, the company will need to determine whether a device made from this material is going to be entirely novel, or whether it can be classified as substantially equivalent to currently approved devices (perhaps the more simple path to market). Further details regarding medical device classification and the approval process will be given in this chapter.

Historical perspective and overview

The Food and Drug Administration (FDA) regulates $1 trillion in products per year, which includes 1.5 million medical devices (Chang, 2003; Swann, 2003). The Center for Devices and Radiological Health (CDRH) within the FDA is responsible for evaluating approximately 4000 new medical device applications each year, as well as monitoring the medical devices already offered on the U.S. market (FDA, 2010). With just over 1200 employees, the CDRH works daily to engage with industry members and physicians in defining the balance between safety, efficacy, and health benefits of medical devices. In addition to the large numbers, the devices approved and monitored by the FDA are also quite diverse, ranging from specialties such as neurology to gastroenterology; from implants as complex as the total artificial heart to items as simple as a bandage.

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References
ASTM, International 2008
ASTM, International 2010 D638–10: Standard Test Method for Tensile Testing of PolymersWest Conshohocken, PAASTM, International
Babiarz, J.C.Pisano, D.J. 2008 Overview of FDA and drug developmentFDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices and BiologicsPisano, D.J.Mantus, D.S.New YorkInforma Healthcare USA, Inc1
Blackstone, E.H. 2005 Could it happen again?: The Bjork-Shiley Convexo-Concave heart valve storyCirculation2717
Chang, M. 2003 Medical Device Regulations: Global Overview and Guiding PrinciplesGeneva, SwitzerlandWorld Health Organization
Dichiara, J. 2008 510(k) Summary for Collagen Scaffold (CS) – K082079Rockville, MDFood and Drug Administration
European Commission 2010 http://ec.europa.eu/consumers/sectors/medical-devices/index_en.htm
Federal Food, Drug, and Cosmetic Act of 1938 1938 1040
Food and Drug Administration 2009 Review of the Regen Menaflex: departures from processes, procedures, and practices leave the basis for a review decision in question, preliminary reportRockville, MDFood and Drug Administration
Food and Drug Administration 2010 Monthly device approvalswww.fda.govRockville, MDFood and Drug Administration
Food and Drug Administration Modernization Act of 1997 1997
Goode, J. S. 2008 510(k) memorandum regarding ReGen Collagen Scaffold (CS)Rockville, MDFood and Drug Administration
Harris, G.Halbfinger, D.M. 2009
Health Canada 2010 http://www.hc-sc.gc.ca/dhp-mps/md-im/index-eng.php
Hilts, P.J. 2003 Protecting America's Health: The FDA, Business and One Hundred Years of RegulationNew York:Alfred A. Knopf
Hines, J.Z.Lurie, P.Yu, E.Wolfe, S. 2010 Left to their own devices: breakdowns in United States medical device premarket reviewPublic Library of Science Medicine 7
International Organization for Standardization 2008 2008 Annual ReportGeneva, SwitzerlandInternational Organization for Standardization
Medical Device Amendments of 1976 1976
Medical Device Amendments of 1992 1992
Medical Device and User Fee Modernization Act of 2002 2002
Medicines and Healthcare Products Regulatory Agency 2008 Medicines & Medical Devices RegulationWhat you need to knowLondonMHRA
Mundy, A. 2009
Orton, J.F. 1907 – its purpose and its authorThe Public 9 1071
Pharmaceutical and Medical Safety Bureau 2010 www.mhlw.go.jp/english/index.html
2008
Sobol, R.B. 1991 Bending the Law: The Story of the Dalkon Shield BankruptcyChicagoUniversity of Chicago Press
Swann, J.P. 2003 History of the FDAThe Food and Drug AdministrationHickman, M.A.Hauppauge, NYNova Science Publishers, Inc9
The Kefauver-Harris Amendments 1962
The Pure Food and Drugs Act of 1906 1906
The Safe Medical Devices Act 1990
Therapeutic Goods Association 2010
Therapeutic Goods Association 2010 http://www.tga.gov.au/devices/devices.htm
Therapeutic Products Directorate 2008 Annual Report 2007–2008Ottowa, OntarioTPD
Tobin, J.J.Walsh, G. 2008 Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical DevicesWeinheim, GermanyWiley-VCH Verlag GmbH & Co