Biomedical Engineering Reference
In-Depth Information
The FDA determines the approval procedures based on the product's classification, which is
categorized as a drug, biological drug, and combination product (device) for human medical
devices. The combination product is a mixture of either drug/biological entity or drug/
device (e.g., tissues or cells combined with a scaffold for wound healing application and
drugs encapsulated in a delivery device).
It is very important for sponsors to comprehend the main requirements for the FDA's
approval process and then develop their product plan. This plan should comprise the correct
and meaningful studies at preclinical and clinical phases in order to validate the safety and
effectiveness of a given product. The sponsor should be provide evidence for a product's
safety and effectiveness, and then regulatory assessment is conducted on a case-by-case
basis. One of the important considerations for tissue engineering products is the assessment
of the preclinical information, such as evolution of toxicity and immunogenicity for local/
systemic responses [10, 11]. Moreover, there are no detailed and exact regulatory mecha-
nisms to provide an outline for introducing tissue engineering into clinical setting in the
European Union (EU).
The FDA Regulations: Human Tissue for Transplantation
The FDA created regulatory outlines for human tissues to prevent the introduction, trans-
mission, or expansion of communicable diseases. The agency's methodologies for regulation
of cellular/tissue-based products are considered in order to avoid use of contaminated tis-
sues with potential to spread infectious diseases such as AIDS and hepatitis. The manufac-
turers of this type of product are demanded to register their company establishments and
then list their products with the Center for Biologics Evaluation and Research (CBER) at
the FDA [12]. Based on the FDA regulation, every specific unit of the tissue-engineered
product must be designed, produced, and assembled in a way that can substitute all the
biological functions of a particular damaged and injured organ. In 1994, the FDA established
a Tissue Engineering Working Group (TEWG) to recognize and report the emerging
scientific and regulatory issues of tissue-engineered medical products (TEMPs). The partic-
ipating members of this group are from FDA centers and offices, the Center for Veterinary
Medicine (CVM), and the Center for Food Safety and Applied Nutrition (CFSAN). This
group is responsible for advancing regulatory consistency for TEMPs through intercenter
communication and cooperation [13, 14]. For example, Biobrane (Bertek Pharmaceuticals)
and Integra (Integra Life Sciences Corp) were the first biologically based wound dressing
products to be approved by the FDA as regulated devices (synthetic materials and animal
tissue products) [15]. The FDA is currently reviewing their regulatory approach for tissue-
engineering products in order to address a wider scope of engineered products and to intro-
duce complete requirements intended for preventing the transmission of communicable
disease (www.fda.gov/cber/tiss.htm).
Ethical Issues
The research subfield of regenerative medicine with the largest number of ethical issues is
that involved in the study of human embryonic stem cells (hESCs). The primary concern
raised in relation to hESC research is the need for donors to consent. Additionally, deriva-
tion of embryonic germ cells from fetal tissue is associated to ethical concerns about
abortion. Currently, there are extensive varieties of national regulations for study on early
embryos and no legislation has been approved in several member states of the USA. In the
