Regulatory Challenges in Biomaterials: Focus on Medical Devices - Biomaterials Science: An Integrated Clinical and Engineering Approach - page 236

Good Laboratory Practices (GLP) are standards adopted by the FDA and reg-
istered in the Code of Federal Regulations that ensure validation of the data
arising from preclinical studies (but not clinical data) of medical products,
including biomaterial-based medical devices. Examples of areas covered
by GLP are organization and personnel, facilities, equipment, records and
reports, and protocols for conducting a non-clinical laboratory study. For
instance, a manufacturer developing new bone cement would have to con-
duct animal studies according to GLP. It is important to note that GLP are
regulations and not just standards, and therefore are mandatory. If at an early
stage of development a manufacturer wants to use a standard other than
those described in GLP, he or she should discuss with an FDA representative
the use of voluntary standards instead of standards specified in GLP [21, 22].
Good clinical practices (GCP) are international standards that provide the
scientific and ethical validity of the clinical data originating in clinical trials
and submitted to the FDA by the manufacturer of a medical product. GCP
include ethical principles, scientific procedures, including how a clinical trial
should be conducted according to a clinical protocol, reporting of adverse
events that could be associated with a medical product, organization and
responsibilities of an Institutional Review Board, audits, informed consent
of human subjects participating in a clinical trial, and all the relevant infor-
mation that is required to ensure protection of any human subject participat-
ing in a clinical study [23, 24].
Now that we have an overview of some of the technical requirements that
are necessary to market a medical product, we will review in more detail
what the pathways are that a medical device should follow to obtain FDA
approval. To review the regulatory aspects of every product and the center
responsible for it, however, goes beyond the scope of this chapter. Instead,
a general description of medical device regulation will be presented. The
importance of understanding medical device regulations in biomaterial
research is evident, since there are presently biomaterials in some 8000 medi-
cal devices. This approach will provide a general idea of how the FDA regu-
lates biomaterials (or at least those that are used in medical devices) [3, 16].
FdA Pathways for the Approval of Medical devices
Medical Devices
Before we start reviewing the FDA pathways for the approval of medical
devices, it might be useful to try to answer the following questions: What
is considered a medical device? Why are medical devices important in
healthcare?
According to the FDA, a medical device is
an instrument, apparatus, implement, machine, contrivance, implant, in
vitro reagent, which is recognized in the United States Pharmacopoeia,
intended for use in the diagnosis of disease or other conditions, or in the