Device Class when used in combination with a device of a higher class?

M

MIREGMGR

#11
Keep in mind that specific classication questions, at least for Class I and II devices, can be asked for free from FDA DSMICA.

You could ask a Class III question as well, but I suspect they might be hesitant to respond without a more formal process and review at a higher level.
 
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G

GPjeri

#12
Wow, this gets complicated. Consider this one please: How about taking a device that would be a class II, (IIb in the EU) and combining it with a class III? Of course in this situation the II is by default a III, but can the class II later be filed as only a 510(k), by itself? Or would the class II manufacturer be smarter to not jump onto the PMA, but get the PMA holder to create a device master file?
 
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