Is Medical Device 510(k) exempt or not really exempt?

Q

QACen

#1
Hello,

Can someone help me understand or give me some insight on this scenario?

Current Machine is an FDA Class II and has an FDA Product Code with a regulation number that states that such machine is exempt from premarket notification regulations.

We make design changes/modifications to the Machine. If the Machine was originally found to be under a regulation number that says it is exempt from premarket notification (intended use is all the same), would this still mean that we would have to undergo premarket notification EVEN if the machine would still fall under the same FDA exempt Product Code?

Thanks a million!
QACen
 
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Elsmar Forum Sponsor
M

MIREGMGR

#2
Re: 510(k) exempt or not really exempt?

If the device was originally classified (correctly) into a Product Code that's Exempt, and that hasn't changed, and FDA hasn't changed any rules or definitions in the meantime, it's still Exempt.
 
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mihzago

Trusted Information Resource
#3
It should still be exempt; however, take a look if there are any "exemptions" from the exemption. Some devices are exempt unless the change you make introduces a new technology or change to the indications for use, which will require a 510(k).

I'm not sure what product code your device is and what the changes are so I cannot comment specifically.
 
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