Is a new 510k needed if modifying to add bluetooth for data transmission?

M

MIREGMGR

For a while now, FDA has been prioritizing attention toward both apps, and technology changes related to data handling and transmission.

My guess is that if there is an uncertainty as to the applicability of the 510(k) guidance, FDA's stance will be that a new review is required; or if you don't get one and go to market anyway, and then your device comes to FDA's attention, that it's illegally marketed.
 

sagai

Quite Involved in Discussions
More or less similar though I have had in my mind.
The other angle to look into this subject is to evaluate purely the business risks and potential consequences lined up in case actually FDA later considers that the 510k should have been submitted. Is it really worthwhile to risk?
Regards
 

Ronen E

Problem Solver
Moderator
The other angle to look into this subject is to evaluate purely the business risks and potential consequences lined up in case actually FDA later considers that the 510k should have been submitted. Is it really worthwhile to risk?

If you consistently apply this line of thought, then every device change requires a 510(k). Why take a business risk? :)
 
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