FDA Approval
Premarket approval (PMA) is the FDA process of scientific
and regulatory review to evaluate the safety and effectiveness
of medical
devices. PMA is the most stringent type of device marketing application
required by FDA. The applicant must receive FDA approval of its PMA
application prior to marketing the device. PMA approval is based
on a determination by FDA that the PMA contains sufficient valid
scientific evidence to assure that the device is safe and effective
for its intended use(s). An approved PMA is, in effect, a private
license granting the applicant (or owner) permission to market the
device. For more information on the Premarket Approval
(PMA) process... click
here.
We
feel it is important for you the consumer to understand how stringent
the process of obtaining premarket
approval and 510K approval can be. The FDA and CDRH take every
measure to ensure the safety of humans and animals. For more information
on the processes
involved with getting a medical device
to market,
please
visit
the following
links:
Medical device manufacturers are required to submit a premarket
notification or 510(k) 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. This database of
releasable 510(k)s can be searched by 510(k) number, applicant,
device name or FDA product code. Summaries of safety and effectiveness
information is available via the web interface for more recent
records. The database is updated monthly.
The
following links provide proof as to the 510(k) approval of
Quantum Devices, Inc. WARP 10®:
As an informed consumer, we do not want you to just take
our word for it. Therefore, the links below allow you to
search for yourself
and find not only the 510(k) Premarket Notification information
about Quantum Devices, Inc. and the WARP 10®, but for our
competitor's products and any other product you may want information
about.
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