The Modern Medicine Show:
The FDA Approval Process for
Karin R. Swartz, MD
University of Kentucky Medical
Joseph S. Cheng, MD, MS
Vanderbilt University Medical Center
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The FDA was established in 1906 within the US Department of Health and Human Services to regulate medical devices
and drugs, and to protect the public against
unethical sales practices and misrepresentation. In 1976, the Medical Device
Amendments (MDAs) to the Federal Food,
Drug and Cosmetic Act of 1938 changed
the process to regulate devices separately
rather than as new drugs. FDA approval of
drugs confirms efficacy, regulating various
aspects from testing, manufacturing, safety,
marketing and labeling. Conversely, the
FDA does not confirm efficacy for devices
—this is a significant difference—but
instead requires compelling evidence for
safety and efficacy.
The Center for Devices and Radiological
Health (CDRH), one of many FDA subdivisions, is responsible for the premarket
approval of all medical devices, overseeing
manufacturing, performance and safety for
all medical devices sold in the United States.
It conducts limited product testing.
oversees myriad devices, from toothbrushes
and cell phones to spinal cord stimulators,
and classifies them into device categories
based on level of risk, intended use and
indications for use.
Class I (General Controls) includes
47% of medical devices. These devices are
considered low risk and have minimal po-
tential for harm. General controls include
manufacturer registration with the FDA,
proper branding and labeling, and general
reporting procedures. Although general
controls may include manufacturing tech-
niques and FDA notification before mar-
keting the device, most Class I devices are
exempt from these two aspects. Given that
these devices, such as adhesive bandages,
confer low risk through normal use, these
general controls are deemed sufficient for
the “reasonable assurance” of their safety
Class II (General Controls with Special
Controls) includes 43% of medical devices
such as X-ray machines, suture, wheelchairs
and thermometers. In addition to general
controls, Class II devices are subject to special controls. Special controls may include
special labeling requirements, mandatory
performance standards and postmarket
surveillance. To avoid injury or harm, these
devices are held to a higher performance
Class III (General Controls and Premarket Approval), the highest risk devices,
comprise about 10% of medical devices.
General and special controls are thought
insufficient to assure safety and effectiveness of pacemakers, breast implants and
other devices for which information is
insufficient. In addtion to all the Class I
and II controls, Class III devices generally
require a scientific review showing safety
and effectiveness before they may be marketed (premarket approval).
2 Devices must
be proven reasonably safe and effective for
their particular use by humans.
3 The approval process for Class III devices requires
submission of supportive clinical data.
Spinal Implants Considered Class III
The FDA regards implanted spinal systems
as significant–risk devices, and thus the
majority are considered Class III. Manufacturers and initial distributors must register
their new spinal implants with the FDA.
Prior to marketing these systems, a sponsor
must obtain permission. For devices substantially equivalent to already approved
implants, a premarket notification (PMN)
or 501(k) submission suffices. For novel
technology, the manufacturer prepares the
much more extensive premarket approval
(PMA, for Class III devices) application.