510(k) Overview
Section 510(k) of the Food, Drug and Cosmetic Act requires those device
manufacturers who must register to notify FDA, at least 90 days in advance, of
their intent to market a medical device. This is known as Premarket Notification
- also
called PMN or 510(k) . It allows FDA to determine whether the device is equivalent
to
a device already placed into one of the three classification categories. Thus,
"new"
devices (not in commercial distribution prior to May 28, 1976) that have not been
classified can be properly identified.
Specifically, medical device manufacturers are required to submit a premarket
notification if they intend to introduce a device into commercial distribution
for the
first time or reintroduce a device that will be significantly changed
or modified to the extent that its safety or effectiveness could be affected.
Such
change or modification could relate to the design, material, chemical composition,
energy source, manufacturing process, or intended use.
Return to 510(k) Homepage
Updated November 15, 1996
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