Regulatory Challenges in Biomaterials: Focus on Medical Devices - Biomaterials Science: An Integrated Clinical and Engineering Approach - page 224

The Importance of Helsinki Declaration in
Current Clinical Research ......................................................................... 265
Conclusions and Future Perspectives .............................................................. 265
Acknowledgments .............................................................................................. 266
References ............................................................................................................. 267
Preface
The field of biomaterials has grown significantly over the last years. The con-
ceptual limits of the discipline have thus become confusing and a matter of
debate. Besides, since it is a multidisciplinary field, a biomaterial may have
many diverse definitions. One of these definitions states that biomaterials
are “materials that are used in medical devices.” This definition is supported
by the fact that biomaterials are being currently used in as many as 8,000
medical devices [1]. In addition, this multidisciplinary concept has an impor-
tant practical significance because biomaterials are being used with multiple
applications in a variety of fields such as stem cells and tissue engineering,
gene therapy, and micro-electro-mechanical/nano-electro-mechanical sys-
tems (MEMS/NEMS) [1, 2]. Moreover, biomaterials are incorporated into a
variety of medical technologies and play a critical role in the failure or suc-
cess of these technologies. These technologies include cardiovascular and
gastrointestinal stents, defibrillators, artificial hips, and pacemakers, all of
which are appearing in increasing numbers in the market. These devices,
which save the lives of millions of people in the world every year, must
be manufactured with appropriate/functional biomaterials for optimum,
robust, long-life performance when implanted in the human body.
The federal government of the United States has created a number of agencies
in charge of ensuring that, once they enter the market, these products will per-
form as expected, without causing harm to the general population. The Food
and Drug Administration (FDA) is the federal regulatory agency involved in
the regulation of biomedical products, including those made of or using bio-
materials. The regulation of biomaterials involves several kinds of products,
each of which is under the jurisdiction of one of the FDA divisions empowered
to control their commercialization by enforcing manufacturers to comply with
standards that ensure the safety and effectiveness of such products [3].
A major objective of this chapter is to focus on some of the regulatory
challenges faced by medical devices containing biomaterials. In addition,
the chapter aims to provide a general picture of the regulatory process for
readers not involved in this subject. Finally, it is the intention of the author
to use this chapter as a reminder of the great importance of these regulatory
agencies, as they are critical for maintaining public health while allowing
the introduction of innovative approaches and technologies in health care.