Biomedical Engineering Reference
In-Depth Information
safe and effective; food is safe, wholesome, and sanitary; and cosmetics are safe.
However, the FDA does not regulate the practice of medicine and leaves areas such
as assisted reproduction unregulated. In addition, the FDA's statute allows it to
regulate only on the basis of safety and efficacy, and not on normative grounds.
The National Institutes of Health (NIH) does have a broader authority to regulate
on the basis of ethical concerns, but its jurisdiction extends only to federally funded
research.
The FDA began as the Division of Chemistry and then (after July 1901) the
Bureau of Chemistry. The modern era of the FDA dates to 1906 with the passage
of the Federal Food and Drugs Act. FDA defines [under 21 CFR 56.102(c)] clini-
cal research as [6]: “Any experiment that involves a test article and one or more
human subjects [or specimens] the results of which are intended to be submitted to
FDA.” The FDA consists of eight centers/offices,
1. Center for Biologics Evaluation and Research (CBER)
2. Center for Devices and Radiological Health (CDRH)—oversees the regula-
tion of electrical medical devices and houses the Office of Device Evalua-
tion (ODE)
3. Center for Drug Evaluation and Research (CDER)
4. Center for Food Safety and Applied Nutrition (CFSAN)
5. Center for Veterinary Medicine (CVM)
6. National Center for Toxicological Research (NCTR)
7. Office of the Commissioner (OC)
8. Office of Regulatory Affairs (ORA)
The FDA also has affiliated organizations including the Joint Institute for Food
Safety and the Applied Nutrition National Center for Food Safety and Technology.
11.5.2 Device Classifi cation
For medical device manufacturers, compliance with the regulatory agencies is a crit-
ical requirement. Recognizing the economic impact of drawing uniform guidelines
for every medical device, regulatory agencies have classified regulatory require-
ments based on the severity of risk to the patient. The FDA has classified medical
devices into three classes: class I, class II, and class III. Similar classifications can
be found in other countries. Accessories used with a medical device to support the
use of the device are considered the same classification as the medical device. Based
on the classification, the FDA determines the needed level of regulatory control to
legally market the device. As the classification level increases, the risk to the patient
and FDA regulatory control increases.
11.5.2.1 Class I Medical Devices
Class I medical devices
are typically those which have a reasonable assurance of
safety and effectiveness, are not life supporting or life sustaining, and do not present
a reasonable source of injury through normal usage. They can be approved through
the 510(k) route to be marketed as general controls. Examples of class I devices are
