Classification of the medical device code and 'subsequent' code

C

celia4237

#1
Dear all:

Now i am classifying a new medical device. And When i search for the similar device in FDA's 510(k) database, i found that there are product code as well as subsequent product code in its 510(k) summary. And this is the first time i meet with " subsequent code", why there is a subsequent code? Is there any difference between the product code and the subsequent product code?
 
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M

MIREGMGR

#3
We have two 510(k)s with a history along those lines.

One, issued in 1978, was totally misunderstood by the inspector when processed. 510(k)s were vastly less detailed back then, and he/she thought that the packaging that was described for the product was itself part of the intended marketable product. So, two product codes were assigned...a primary, and a subsequent for the packaging material. Kind of strange, but it was over 30 years ago.

The other was from the '80s, and involved a product that was originally classified into a code that the FDA has since discontinued, applicable to "general medical devices not otherwise defined". When that code was discontinued, a "subsequent" code (as recommended by us) was assigned.

I'm guessing that neither of these examples will illuminate your question.

You might want to call FDA DSMICA and ask them for an explanation of the particular 510(k) you have in mind. They could require you to file a FOIA request, but my guess is they won't if you make clear that your only interest is in an explanation of the code assignment.
 
Y

yana prus

#4
Hi Celia,

Product Code is a primary code, while subsequent product code is a secondary code, for additional feature(s) that predicate devices of the primary code don't have. In that way the device is a combo device - it is a combination (or extension) of the intended use as well as features. For the secondary code, there might be specific FDA standards and guidances that the device has to comply with.

Hope that helps.

Yana
 
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