Biomedical Engineering Reference
In-Depth Information
A subject may be coerced by fear that there is no other recourse for treatment, by the fear
that nonconsent will alienate the physician on whom the subject depends for treatment,
or even by the fear of disapproval of others. This sort of coercion, if it truly ranks as such,
is often difficult to detect and, in turn, to remedy.
Finally, individuals must understand what they are consenting to do. Therefore, they
must be given information sufficient to arrive at an intelligent decision concerning whether
to participate in the research. Although a subject need not be given all the information a
researcher has, it is important to determine how much should be provided and what can
be omitted without compromising the validity of the subject's consent. Another difficulty
lies in knowing whether the subject is competent to understand the information given
and to render an intelligent opinion based upon it. In any case, efforts must be made to
ensure that sufficient relevant information is given and that the subject is sufficiently com-
petent to process it. These are matters of judgment that probably cannot be made with abso-
lute precision and certainty, but rigorous efforts must be made in good faith to prevent
research on humans from involving gross violations of human dignity.
2.9
REGULATION OF MEDICAL DEVICE INNOVAT
ION
The Food and Drug Administration (FDA) is the sole federal agency charged by Con-
gress with regulating medical devices to ensure their safety and effectiveness. Unlike food
and drugs, which have been regulated by the FDA since 1906, medical devices first became
subject to FDA regulation in 1938. At that time, the FDA's major concern was to ensure
that legitimate medical devices were in the marketplace and were truthfully labeled, not
misbranded. Over time, the scope of FDA review of medical devices has evolved, as has
the technology employed by medical devices). The first substantive legislative attempt to
address the premarket review of all medical devices occurred with the Medical Device
Amendment of 1976 (Pub. L. No. 94-295, 90 Stat. 539). This statute requires approval from
the FDA before new devices are marketed and imposes requirements for the clinical inves-
tigation of new medical devices on human subjects. For details related to the FDA process,
visit http://www.fda.gov/.
The FDA is organized into five major program centers: the Center for Biologics Evalua-
tion and Research, the Center for Drug Evaluation and Research, the Center for Food Safety
and Applied Nutrition, the Center for Veterinary Medicine, and the Center for Devices and
Radiological Health (CDRH). Each FDA program center has primary jurisdiction over a
different subject area. According to the FDA, the CDRH is responsible for ensuring the
safety and effectiveness of medical devices and eliminating unnecessary human exposure
to man-made radiation from medical, occupational, and consumer products.
The CDRH has six distinct offices: the Office of Systems and Management, the Office of
Compliance, the Office of Science and Technology, the Office of Health and Industry Pro-
grams, the Office of Surveillance and Biometrics, and the Office of Device Evaluation
(ODE). The ODE has several principal functions, including the following:
Advising the CDRH director on all premarket notification 510(k) submissions, premarket
approvals (PMAs), device classifications, and investigational device exemptions (IDEs).
