PERSPECTIVE
safety and effectiveness. It is
important to maintain and en-
courage innovation in medical
devices. But true innovation re-
quires that safety and effective-
ness be proven by scientific
study in clinical trials.
Unfortunately, the FDA leader-
ship has already suggested that it
does not intend to implement this
key recommendation of the re-
port, although it may be open to
other changes. As the best long-
term improvements are contem-
plated, there are important steps
that the agency can take now.
First, the use of 510(k) clear-
ance for class III devices should
stop, as Congress made clear 20
years ago. A substantial equiva-
lence standard for clearance of
such complex devices is untenable.
Second, the use of multiple
predicates in 510(k) clearance
should be eliminated. Now a de-
vice may be cleared if it is found
to be substantially equivalent to an
existing device that was cleared,
in turn, by being found substan-
tially equivalent to another device,
and so on. This tenuous process
should be discontinued.
Medical Devices and Health Creating a New Regulatory
Framework for Moderate-Risk Devices
David R. Challoner, M.D., and William W. Vodra, J.D.
T he recently released Institute
of Medicine (IOM) report Med-
ical Devices and the Publics Health:
The FDA 510(k) Clearance Process at
35 Years recommends that the
Food and Drug Administration
(FDA) begin to develop a new
regulatory framework for mod-
erate-risk (class II) medical de-
vices.1 Regulation of devices be-
gan in 1938, and the regulatory
structure reflected the relative
The New England Journal of Medicine
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Copyright 2011 Massachusetts Medical Society. All rights reserved.
Medical Devices Balancing Regulation, Innovation
Third, as was recommended future, and despite well-financed
by the IOM committee, a formal
system of postmarketing sur-
veillance for medical devices
should be put in place. Strong,
mandatory, and transparent
postmarketing data, in regis-
tries, allow rapid identification
of serious problems that may
emerge after approval. Careful
tracking of every patient with a
high-risk device is a crucial step
for ensuring patient safety and
avoiding nightmare scenarios.
We strongly believe that, in
the interest of advancing human
health, patients must have easy
access to innovative medical de-
vices and that the approval pro-
cess needs to be sensible and
efficient. But no ones interest is
served by putting defective med-
ical devices onto the market
where they cause harm to pa-
tients, waste health care dollars,
and may kill jobs when they are
withdrawn. It is essential that
the FDA be adequately funded to
carry out its mission to ensure
the safety and effectiveness of
medical devices. The IOM report
charts a path that is right for the
simplicity of the devices that
were on the market at that time.
By the 1970s, the original regu-
latory framework was no longer
adequate or flexible enough to
deal with the growing array of
device types and the increasing
sophistication of new devices.
Sporadic public health disasters
associated with a few devices gen-
erated substantial public concern.
Consequently, Congress passed
n engl j med 365;11 nejm.org september 15, 2011
outside pressures, we urge the FDA
to initiate an action plan with con-
gressional support to adopt these
important recommendations.
Disclosure forms provided by the au-
thors are available with the full text of this
article at NEJM.org.
Dr. Curfman is the Executive Editor of the
Journal, and Dr. Redberg is the Editor of the
Archives of Internal Medicine, San Francisco.
This article (10.1056/NEJMp1109094) was
published on August 10, 2011, at NEJM.org.
1. National Hospital Discharge Survey: sur-
vey results and products. Atlanta: Centers
for Disease Control and Prevention, 2009.
(http://www.cdc.gov/nchs/nhds/nhds_
products.htm.)
2. Updated guidance on large diameter met-
al on metal bearing total hip replacements.
London: British Hip Society and British Or-
thopaedic Association, March 2011. (http://
www.britishhipsociety.com/pdfs/BHS_
MOM_THR.pdf.)
3. Testimony of Katherine Korgaokar before
the Senate Committee on Aging, Washing-
ton, DC, April 13, 2011. (http://aging.senate
.gov/events/hr233kk.pdf.)
4. Institute of Medicine. Medical devices
and the publics health: the FDA 510(k) clear-
ance process at 35 years. Washington, DC:
National Academies Press, 2011.
5. Challoner DR, Vodra WW. Medical devices
and health creating a new regulatory
framework for moderate-risk devices. N Engl
J Med 2011;365:977-9.
Copyright 2011 Massachusetts Medical Society.
the Medical Device Amendments
of 1976,2 which established the
framework for the current system.
In 1990 and 1997, Congress enact-
ed significant changes to the orig-
inal statute.3
The law is now designed to re-
quire extensive FDA review and
premarketing approval for high-
risk (class III) devices (e.g., im-
plantable heart valves, intraocular
lenses, and stair-climbing wheel-
977
PERSPE C T I V E
chairs), no premarketing review
for most low-risk (class I) devices
(such as tongue depressors, pre-
scription eyeglasses, and manual
wheelchairs), and a limited review
for class II devices (e.g., most la-
sers and magnetic resonance im-
aging devices, hard contact lenses,
and battery-powered wheelchairs)
through the 510(k) process (named
for the statutory provision from
which it is derived). The standard
for approval of class III devices is
safety and effectiveness, while the
legal standard for 510(k) clearance
is substantial equivalence to a
previously cleared predicate de-
vice. The underlying assumption is
that if a new device is equivalent
to a previous similar device, it will
be at least as safe and effective
as that device. The FDA may re-
quest preclinical or even clinical
data to support the claim of sub-
stantial equivalence, but the agen-
cy has stated, and the U.S. Su-
preme Court has agreed, that a
finding of substantial equivalence
is not a determination that a de-
vice is safe and effective.4,5
Today, we have a system in
which a new moderate-risk de-
vice can enter the market be-
cause it is substantially equiva-
lent to another device that may
have been cleared for marketing
2 years ago because its manu-
facturer showed that it was sub-
stantially equivalent to yet an-
other device cleared in 2003,
and so on, all the way back to a
device that was being marketed
when the law was enacted in
1976. But that original device
might never have been assessed
for safety or effectiveness, nor
perhaps would any subsequent
ones in the family tree. More-
over, a novel device without any
single product to which it is
similar can be cleared by having
978
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Copyright 2011 Massachusetts Medical Society. All rights reserved.
various characteristics that are
equivalent to individual traits of
two, three, or more different
previously cleared devices. These
prior devices do not even have to
be marketed, so there may be no
real-world experience to provide
a basis for assessing safety or
effectiveness even if we had a
high-quality postmarketing sur-
veillance system to capture this
experience.
When the IOM Committee on
the Public Health Effectiveness
of the FDA 510(k) Clearance
Process, on which we served,
began its work in early 2010, it
did not grasp the weaknesses in
this system. After careful study,
we concluded that the time has
come for a forward-looking reg-
ulatory system, rather than one
focused on past products. The
committee concluded that the
current 510(k) process, in which
the standard for clearance is
substantial equivalence to previ-
ously cleared devices, should be
replaced with an integrated pre-
marketing and postmarketing
regulatory framework that gives
reasonable assurance of safety
and effectiveness throughout
the device lifecycle. Furthermore,
we decided that the 510(k) pro-
cess cannot be transformed into
a premarketing evaluation of safe-
ty and effectiveness as long as
the standard for clearance is sub-
stantial equivalence to a previ-
ously cleared device.
That conclusion led to the com-
mittees recommendation that a
new regulatory framework is need-
ed for moderate-risk devices. The
report does not specify in detail
what this new framework should
be. The FDA needs to obtain ade-
quate information, which does not
currently exist, to inform the de-
sign of the new framework. The
n engl j med 365;11 nejm.org september 15, 2011
The New England Journal of Medicine
Medical Devices and Health
report does, however, include a list
of ideal attributes of the frame-
work, indicating that the process
should be based on sound science;
be clear, predictable, straightfor-
ward, and fair; be self-sustaining
and self-improving; facilitate inno-
vation that improves public health
by making devices available in a
timely manner and ensuring their
safety and effectiveness through-
out their lifecycle; apply relevant
and appropriate regulatory author-
ities and standards throughout de-
vices lifecycle to ensure safety and
effectiveness; and be risk-based.
No premarketing review by
itself will ever be enough to pro-
vide reasonable assurance of de-
vices safety and effectiveness.
Adequate postmarketing oversight
is also necessary for a compre-
hensive regulatory framework, and
todays FDA confronts substantial
deficiencies in this area. Before
the FDA begins to create a new
framework, it should strengthen
its ability to collect, analyze, and
act on postmarketing perfor-
mance information for devices.
It should also review its post-
marketing enforcement tools for
devices (e.g., seizing, banning,
and recalling of devices) to iden-
tify existing limitations on their
use and to determine how those
limitations can be addressed. It is
highly conceivable that a better
postmarketing oversight system
will reduce the burdens of pre-
marketing review.
The FDA has also lacked a
system of continuous quality im-
provement for its device program.
It should develop and implement
such a system to increase predict-
ability, transparency, and consis-
tency in all regulatory decisions
for devices and to address emerg-
ing issues that affect decision
making.
PERSPECTIVE Medical Devices and Health

The information that would be
needed to determine how much
and in what way innovation is
influenced by the 510(k) process
is not available. The FDA should
gather that information by com-
missioning a study to assess
whether its regulatory process
for class II devices facilitates or
inhibits innovation in the medi-
cal-device industry.
Increased postmarketing over-
sight, particularly postmarketing
surveillance, implementation of a
continuous quality-improvement
program, assessment of innova-
tion, and other actions recom-
mended by our committee some
of which were already being un-
dertaken by the FDA before our
report was released will yield
both short-term and long-term
benefits. These activities will pro-
vide information for the design
of the new framework. Once the
necessary information has been
collected, the FDA should work
with the medical-device industry,
consumers, health care providers,
payers, and Congress to design the
new framework.
Each year, several thousand
devices about one third of
devices entering the market
are cleared through the 510(k)
process. Although the continu-
ous use of many of these devices
in clinical practice provides a
level of confidence in their safety
and effectiveness, what patients
want is reasonable assurance that
a device is clinically effective and
that its benefits outweigh its
risks not merely an indication
that it is substantially equivalent
to another device. The 510(k)
process cannot provide that as-
surance. Now is the time to
move forward with designing a
comprehensive regulatory frame-
work for the next 35 years and
beyond.
Disclosure forms provided by the authors
are available with the full text of this arti-
cle at NEJM.org.
Dr. Challoner is the vice president for health
affairs, emeritus, University of Florida,
Gainesville, and was the chair of the IOMs
Committee on the Public Health Effective-
ness of the FDA 510(k) Clearance Process;
Mr. Vodra is senior counsel (retired), Ar-
nold and Porter, LLP, Washington, DC, and
was a member of the IOM committee.
This article (10.1056/NEJMp1109150) was
published on August 10, 2011, at NEJM.org.
1. Institute of Medicine. Medical devices
and the publics health: the FDA 510(k) clear-
ance process at 35 years. Washington, DC:
National Academies Press, 2011.
2. Medical Device Amendments of 1976,
Pub. L. No. 94-295, 90 Stat. 539 (1976).
3. Safe Medical Devices Act of 1990, Pub. L.
No. 101-629, 104 Stat. 4511; Food and Drug
Administration Modernization Act of 1997,
Pub. L. No. 105-115, 111 Stat. 2296 (1997).
4. Federal policies and the medical devices
industry. Washington, DC: Office of Tech-
nology Assessment, 1984:128.
5. Medtronic, Inc. v. Lohr, 518 U.S.470.
Copyright 2011 Massachusetts Medical Society.

n engl j med 365;11 nejm.org september 15, 2011 979

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