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" Frequently Asked Questions "
A medical device is an instrument, apparatus, implement,
machine,
contrivance, implant, in vitro
reagent, or other similar or re
lated article, including any com
ponent, part, or accessory, which
is—
•
recognized in the official National Formulary,
or the United States Pharm
acopeia, or any
supplement to them,
•
intended for use in the diagnosis of disease or
o
ther conditions, or in the cure, mitigation,
treatment, or prevention of diseas
e, in ma
n or other animals, or
•
intended to affect the structur
e or any function of the body of
man or other anim
als, and
which does not achieve its primary intended purpo
ses through chemical action within or on the
body of m
an or other animals and which is no
t dependent upon being metabolized for the
achievement of its primary intende
d purposes (21 U.S.C. 321(h)).
How does FDA classify medical devices?
In acco
rdance with the Federal Food, Drug, and Cosmetic Act, FDA places all medical devices
into one of three regulatory classes b
ased on the le
vel of control necessary to ensure safety and
effectiveness of the device. Classification is risk
based, that is, the risk the device poses to the
patient and/or the user is a major factor in determining the class to which it is assigned.
Devices in all three classes are su
bject to general controls which re
quire, in part, that comp
anies:
(1) register their establishments and list th
e medical devices they market with FDA; (2)
manufacture their devices in accordance with G
ood Manufacturing Practices
; and (3) label their
devices in accordance with labeling regulations.
Class I devices
are subject only to general
controls. They typically p
resent the lowest potential
for harm and are simpler in design than Class II
or Class III devices. Examples of Class I
devices include elastic bandages, examination
gloves, and hand-held surgical instruments.
Class II devices
are those for which general controls
alone are insufficient to provid
e a
reasonable assurance of safety and effectiveness.
In addition to complying with general controls,
Class II devices are also subject to special cont
rols identified by the agency, which may include
special labeling requirements, performance standards and postmarket surveillance. Examples of
Class II devices include powered wheelchairs,
infusion pumps, and surgical drapes.
Class III devices
genera
lly are those for which insufficient information exists to determine that
general or special controls are sufficient to
provide a reasonable assurance of safety and
effectiveness. Examples of Class III devices incl
ude replacement heart valves, silicone gel-filled
breast implants, and implante
d cerebellar stimulators.
Examples of medical devices incl
ude surgical lasers, wheelchairs,
sutures, pacema
kers, vascular
grafts, intraocular lenses, and ort
hopedic pins. A longer list of exam
ples of medical devices is in
the FDA Information Sheet Guidance, “Significa
nt Risk vs. Non-Significant Risk Devices.”
Medical devices also include diagnostic products
. Examples of diagnostics include in vitro
diagnostic reagents and test kits
such as pregnancy test kits, and im
aging systems such as
magnetic resonance imaging (MRI).
