Biomedical Engineering Reference
In-Depth Information
Chapter 17
FDA Regulation of
Polyaryletheretherketone Implants
*
Jove Graham Ph.D. and Jonathan Peck M.E.
17.1 Introduction
Agency) in the United Kingdom, the TGA (Thera-
peutic Goods Administration) in Australia, or the
MHW (Ministry of Health and Welfare) in Japan. As
part of the executive branch of the federal government,
the FDA does not write or create laws as Congress
does, but its job is to enforce laws pertaining to food,
drugs, medical devices, and other related products.
Part of enforcing those laws is guaranteeing to the
American public that companies are manufacturing
and selling medical products that are reasonably safe
and effective and that they are representing those
products to the public in an honest, accurate way.
The FDA is responsible for ensuring the safety
and/or efficacy of food (except for meat, poultry, and
some dairy products, which are overseen by the US
Department of Agriculture), drugs, medical devices,
biologics (such as vaccines and tissue or blood
transplants), animal food and drugs, cosmetics, and
radiation-emitting products (for medical or nonmed-
ical uses). The FDA divides these responsibilities
among seven centers, one of which is the Center for
Devices and Radiological Health (CDRH). The
CDRH regulates a wide range of medical devices
such as tongue depressors, latex gloves, magnetic
resonance imaging (MRI) machines, and pacemakers.
It has been estimated that there are more than 1800
types of medical device sold in the United States
today, with more than 70,000 different individual
products. More than 20,000 companies sell medical
devices in the United States, and greater than 90% of
these are considered as small businesses (i.e., fewer
than 500 employees). Thus,
In the preceding chapters of this topic, you have
read about the properties of polyaryletheretherketone
(PEEK) and its use in several types of orthopedic and
spinal device applications. This chapter is designed to:
(1) provide an overview of the main regulatory body
for medical devices in the United States, the Food
and Drug Administration (FDA);
(2) explain how devices are regulated by the FDA;
(3) explain the pathways by which new devices apply
for regulatory approval;
(4) explain how the FDA regulates device materials
such as PEEK and give examples of spinal
devices that have been approved by the FDA; and
(5) explain how Master Files and standards are used
in the regulation of device materials such as
PEEK.
17.2 What Is the FDA?
The FDA is a science-based regulatory and law
enforcement agencywithin the executive branch of the
US federal government. There are similar agencies in
countries around the world, such as the MHRA
(Medicines and Healthcare Products Regulatory
*
This chapter reflects the views of the authors and should not be
construed to represent the FDA's views or policies.
the medical device
