Existing Device + Existing Device = OK ? New 510(k) required?

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C

celia4237

#12
I hope you recognize that the issues you present, i.e. continued legal marketability of an existing product after changes to that product have been made, should have been addressed when you made those changes... at least if that product is still on the market.

In any case, the bottom line is that you must address the questions in the decision flowchart that Al Rosen linked above.

If the changes to your existing device were "documentation only", then you did not "form a new device". Instead you just created a variant of your already-existing device, and the existing 510(k) would continue to apply.
Old thread, but new question. I wonder what do you mean by "variant"? can a variant of the legally marketed device use a different name? for example, the legally markted device is call YY010, and we have modify the colour of the device, (the modification will need no new 510(k), and "documentation" is enough) and call the colour-changed device YY020, then if the YY020 can be put on the market without a 510(k) submission? I mean, there is YY010 listed on the 510(k) clearance letter and in FDA's database, but YY020 is not there!

Thanks a lot!
 

Al Rosen

Staff member
Super Moderator
#14
Old thread, but new question. I wonder what do you mean by "variant"? can a variant of the legally marketed device use a different name? for example, the legally markted device is call YY010, and we have modify the colour of the device, (the modification will need no new 510(k), and "documentation" is enough) and call the colour-changed device YY020, then if the YY020 can be put on the market without a 510(k) submission? I mean, there is YY010 listed on the 510(k) clearance letter and in FDA's database, but YY020 is not there!

Thanks a lot!
What I did in a similar situation was to write a letter to the FDA explaining the difference between the existing product and the new product along with the reason that I believed that a new 510(k) was not required. The FDA responded with a letter in concurrence. When a customer requested proof of registration, I sent a copy of that letter from the FDA along with a copy of the original 510(k) letter.
 
C

celia4237

#16
What I did in a similar situation was to write a letter to the FDA explaining the difference between the existing product and the new product along with the reason that I believed that a new 510(k) was not required. The FDA responded with a letter in concurrence. When a customer requested proof of registration, I sent a copy of that letter from the FDA along with a copy of the original 510(k) letter.
Your experience seems great! Thanks a lot. I would like to try it! Thank you Al Rosen!
 
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