Regulatory Challenges in Biomaterials: Focus on Medical Devices - Biomaterials Science: An Integrated Clinical and Engineering Approach - page 260

of safety and effectiveness if deemed necessary. This was also applied to
medical devices. For instance, current Class I or Class II medical devices not
otherwise subjected to 510k could require a 510k when using a nanomaterial
if the added change surpasses the limit established by the Code of Federal
Regulations (CFR) regarding exemptions for devices that are similar to ones
existing in the market (21 CFR 878.9). In addition, a new 510k application
could be required from the FDA to an already cleared Class I or Class II
product when incorporating nanoscale materials [77, 78].
Concerns Regarding New Technologies among the General Population
As new technologies are created, new regulatory gaps in the regulation arise
as a consequence of the increasing complexity and uncertainty of such tech-
nologies. We mentioned as an example micro and nanotechnologies, but
the same trend could be seen in other disciplines using biomaterials such
as tissue engineering and gene therapy. The finding of a genetically modi-
fied organism (GMO), the finding of lead in toys, the alarming discovery of
contaminated peanuts, and the presence of Escherichia coli bacteria in meat
has raised increasing outrage within the general population in terms of how
federal agencies will afford the challenge of new technology regulation. It
is important to point out that the main beneficiary of new technologies is
the society. A recent report from the Woodrow Wilson Center Project on
Emerging Nanotechnologies mentioned that the public trust in the manner
in which regulatory agencies are dealing with new technologies has declined
over the last years. This can be explained by the fact that public confidence is
based on a benefit/risk ratio where high benefits are expected from high risk
or undetermined risk products. Because of the incremental benefit of nano-
technologies at this time of development, and the great amount of uncer-
tainty existing among toxicological issues of nanotechnology products, it is
legitimate to wonder whether the public will accept such a balance [80, 81].
Ethical Challenges
Ethics vs. Economics
Why do we need to write about ethics in a book about biomaterials? As we
have seen during the course of this chapter, biomaterial and device develop-
ment is a process that takes place through several steps, including design
and fabrication, in vitro testing, preclinical or animal testing, and ultimately
clinical trials. It is important to point out that clinical trials where human
subject research was carried out without considering the ethical aspects
involved in conducting experimental work in human subjects, some histori-
cal tragedies took place (Figure 10.7). Therefore, it should be realized that
biomaterial development is a process where ethical considerations must be
applied with the same rigor as with any other technical requirement.