Biomedical Engineering Reference
In-Depth Information
embraces the life, physical and engineering sciences to improve failed biological functions
due to congenital abnormalities, disease, and aging.
For successful translation of research in regenerative medicine into products for the
clinical application and marketplace, the integration of sciences with several key factors,
such as market opportunity, public/private funding, regulatory approval, cost reimburse-
ment, and public perception, is an indispensable requirement [5]. The FDA has developed
proper strategies for the regulatory oversight of tissue-based products since 1990 that cover
most of the engineered products. Some of these strategies, such as ethical concerns, are
potential barriers to the further commercial development of regenerative medicine.
Legislative Authority
The responsibility for management of the artificial organs/tissues and their commercializa-
tion inside the US Federal Government has been distributed among several regulatory
agencies, such as the Health Resources Services Administration (HRSA). These agencies
manage the organ transplantation and bone marrow donor program. The FDA as a science-
based regulatory agency in the US Public Health Service (PHS) regulates the remaining
products [5]. The PHS regulates the legislative authority for premarket approval and
post-market surveillance [8]. The FDA is responsible for the evaluation of tissue-engineered
products in gaining approval for the marketplace, and takes corrective action to eliminate
products from the marketplace when they are unsafe, misbranded, or corrupted (Figure 22.1).
The FDA assures the safety of foods, cosmetics, and also the effectiveness of human and
veterinary pharmacological agents together with biological/medical devices. These agencies
are composed of different centers and offices: Center for Biologics Evaluation and Research
(CBER), Center for Devices and Radiological Health (CDRH), Office of Regulatory Affairs
(ORA), Office of Orphan Products (OOP), and Office of Combination Products (OCP) [9].
Medical device
Low risk and exempt
from intense
premarket evaluation?
OK
No
Compliance with
good manufacturing
practices?
Similar to previously
approved, legally marketed
“predicate” device?
Ye s
Ye s
Registration
and
listing
Premarket approval application
mandated by FDA
for this type of device?
Figure 22.1
The pathway for medical device development from initiation stage, to product launch,
to the premarket evaluation stage.
