Two Identical Medical Devices put in different Classes - Class I and Class II

A

adg189256

#1
I am wondering how two identical devices were put into two separate classes.

The two are Invisalign and OrthoClear.

Invisalign is listed by the FDA under NXC 872.5470 class II. This is the sequential aligner sub-division of the plastic bracket classification.
The FDA moved them from their original designation as a ?Preformed Tooth Positioner? (872.5525) class I in 2006.

Orthoclear, an identical product, was classified as an orthodontic band. (872.5410) which is class I. They were not effected by the FDA?s ruling that change the preformed tooth positioner to plastic bracket.

How is this possible, and how to I make sure a new device falls under the class I designation?

Thanks!
 
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M

MIREGMGR

#3
I am wondering how two identical devices were put into two separate classes. (...) How is this possible, and how to I make sure a new device falls under the class I designation?
This has happened many times...sometimes because the boundary between classifications is poorly defined and a device-type legitimately can be considered to be either, and sometimes because a maker erroneously or deviously mis-classifies.

It can happen Class I <--> Class II when one maker classifies as Class I, documents to file, and Lists per their own determination, and another maker classifies as Class II, submits a 510(k) application to FDA and is approved.

In addition to the many illogical boundaries in the classification system, there is at least one, and probably other, device types that are defined twice, once as Class I, once as Class II.

It also can happen Class II <--> Class II. There are several places in the classification system where a common product type can be considered to fit into one classification per one valid decision logic, and into another classification per another valid decision logic.

FDA has no mechanism for reviewing that Class I self-classifications are always correct, and no process for fixing the very inconsistent classification system itself so that the boundaries and the decision logic to be applied in a given instance are clear.

If you want/need a given classification, it's up to you to manage the system so that you end up with it.
 
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