Regulatory Challenges in Biomaterials: Focus on Medical Devices - Biomaterials Science: An Integrated Clinical and Engineering Approach - page 231

in 1962, which caused severe birth defects, including heart defects and miss-
ing limbs, a new law known as the Kefauver-Harris Drug Amendments Act
was passed to strengthen the power of the FDA to monitor drug safety in the
United States [46]. In 1976, the creation of the Medical Device Amendment
Act came to be the first medical device regulation in the United States. This
amendment called for quality control procedures and the registering of man-
ufacturers of medical devices with the FDA [16, 17]. In 1990, the Safe Medical
Device Act required safety studies and reporting from public institutions
of any adverse event that could be related to a particular medical device.
In addition, device manufacturers were required to perform safety moni-
toring of implantable medical devices in the form of post-marketing safety
studies, including reports and tracking of the patients using their products.
In 1997, the Food and Drug Administration Act was approved. By this act,
the FDA reaffirmed its commitment to protect public health by ensuring the
safety of foods and the effectiveness and safety of drugs, medical devices,
and radiation-emitting products. This act sought also to improve the label-
ing of these products, consult with experts of every field about every aspect
involved in public health protection, and decrease the level of bureaucracy
and improve harmonization with other regulatory agencies worldwide. In
2002, the Medical Device User Fee and Modernization Act was incorporated.
In addition, the Office of Combination Products was created [16, 17]. The 2002
act incorporated fees for the premarket approval of devices, allowed for the
inspection at the manufacturer site by third parties, and introduced new
regulations in reprocessed single-use devices [16, 17].
FDA Organization and Operation
FdA Organization
To address the question of how the FDA is able to regulate almost one quar-
ter of the products sold in the United States, it is important to understand
its organization. To achieve its goals, the FDA is organized into six product
centers, one research center, and two offices: the Center for Biologics and
Evaluation Research (CBER), the Center for Drug and Evaluation Research
(CDER), the Center for Food Safety and Applied Nutrition (CFSAN), the
Center for Tobacco Products (CTP), the Center for Veterinary Medicine
(CVM), the Center for Devices and Radiological Health (CDRH), the National
Center for Toxicological Research (NCTR), the Office of Regulatory Affairs
(ORA), and the Office of the Commissioner.
Center for Biologics and Evaluation Research (CBER): The CBER is in
charge of the regulation of a wide variety of products, such as gene
therapy, blood and blood components, vaccines, tissues (such as