FDA Approved Class II Medical Device?

Watchcat

Trusted Information Resource
#11
Well, possibly it is logical to use that device, but not because it is FDA approved, since it isn't, but because it is FDA cleared. That means that a device of this type isn't subject to FDA approval, so FDA cleared is as "golden" as it gets, and I can see the logic that FDA clearance is the gold standard for this device type. The problem here is that, in most cases, FDA will have cleared a number of devices under the same product code, so "FDA cleared" as the gold standard doesn't quite translate to that specific device being THE gold standard.

In summary, here's the logical option, I think:

FDA cleared is the gold standard, so we are going to validate our device against an FDA cleared device.
 
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Ronen E

Problem Solver
Staff member
Moderator
#12
Gold standard or not, you are definitely expected to utilise the predicate in your evaluation & clearance process. Exactly how to utilise, and to what extent, involves some flexibility (refer to the 510(k) / substantial equivalence determination guidance), but this "flexibility" is confined within some pretty rigid boundaries.

All that is not particularly related to "FDA approved", actually...
 
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