Biomedical Engineering Reference
In-Depth Information
12
Clinical and Regulatory
Challenges for Medical Devices
The term 'medical devices' covers a vast array of products, from simple tongue depressors
to magnetic resonance equipment. The intended primary mode of action of a medical
device on the human body, in contrast to that of medical products, is not metabolic,
immunological, or pharmacological, although it may be assisted in its function by such
means. With around 1.5 million different devices available, it is one of the fastest growing
markets today. As a consequence, the regulatory approval and licensing of medical devices
is becoming more and more challenging.
All medical devices, including minimally invasive surgical (MIS) and minimally inva-
sive robotic surgical (MIRS) devices are governed by strict regulatory controls. Through
various regulatory bodies, the US Department of Health and Human Services (HHS),
and similar agencies in other countries, protect the public from a number of health risks
and provides programs for public health and welfare. Together, these regulatory agen-
cies protect and regulate public health at every level. For instance, the US Food and
Drug Administration (FDA) is the federal regulatory agency responsible for public health
through the regulation and supervision of food safety, tobacco products, dietary supple-
ments, prescription, and over-the-counter pharmaceutical drugs (medications), vaccines,
biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emit-
ting devices (ERED), veterinary products, cosmetics, food additives, product recalls, and
restaurant inspection.
12.1 Clinical Issues
Medical devices remain distinct from drugs for regulatory purposes due to the fact that they
operate via physical or mechanical means and are not dependent on metabolism to accom-
plish their primary intended effect. As defined in the federal Food, Drug, and Cosmetic
