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Biometrix - FDA-510K and Usability Studies

Biometrix - FDA-510K and Usability Studies

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Biometrix - FDA-510K and Usability Studies
Biometrix - FDA-510K and Usability Studies

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Published by: gabababa on Aug 21, 2008
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05/09/2014

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Biometrix Corporation 800-890-8901
FDA- 510K andUsability Studies
 
Biometrix Corporation 800-890-8902
Premarket Notification 510(k)
A 510(k) is a premarket submission made toFDA to demonstrate that the device to bemarketed is at least as safe and effective, thatis, substantially equivalent, to a legally marketeddevice (21 CFR 807.92(a)(3)) that is not subjectto PMA (Premarket Approval). Submitters mustcompare their device to one or more similar legally marketed devices and make and supporttheir substantial equivalency claims.
 
 
Biometrix Corporation 800-890-8903
Premarket Notification 510(k)
cont’d
The device to which the new device is compared is known as thepredicate.
A device is substantially equivalent (SE) if, in comparison to apredicate it:
has the same intended use as the predicate;
and
 
has the same technological characteristics as the predicate;
or 
 
has the same intended use as the predicate;
and
 
has different technological characteristics and the informationsubmitted to FDA;
does not raise new questions of safety and effectiveness;
and
 
demonstrates that the device is at least as safe and effective as thelegally marketed device.

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