Can we change the ProCode if a better one is found?

[Mark Meer]

We have a Class II (510(k) exempt) device, currently listed under a given product code.

I'm now looking at other ProCodes and have found one that is an even more accurate description of the device. Trouble is, it is a different class (Class I).

Questions:
1. How onerous is it to change a product code (assuming it can be done)?
2. Can it be done if the classification changes (Class II -> Class I)? (note: no 510(k) is involved, as the original procode is 510(k) exempt)

 

[JeantheBigone]

If both procodes are really for exempt devices, and both describe your device, there is an easy part and a hard part.

The easy part is to log into your FURLS account and update the listing information. That takes about 10 minutes.

The hard part, if the procodes apply to devices that are not exempt from GMP regulations, is to add a document to the DHF describing why the procode was not accurately chosen in the first place, what has changed etc.

 

[Mark Meer]

...
The easy part is to log into your FURLS account and update the listing information. That takes about 10 minutes. ...

I contacted the FDA device listing help desk via email, and they told me that ProCodes on existing listings cannot be changed. They suggested I would have to create a new listing (under the new product code), and then deactivate the old listing.

...The hard part, if the procodes apply to devices that are not exempt from GMP regulations, is to add a document to the DHF describing why the procode was not accurately chosen in the first place, what has changed etc.

This is the complication I'm seeking guidance on. The old ProCode is Class II, 510(k) exempt, and the new one is Class I (no 510(k)), and GMP exempt. Obviously this change in ProCode would be a downgrade in regulatory-burden, so I presume it's not as simple as just creating a new listing and deactivating the old one...

Am I correct that all we have to do is justify in our internal documentation (i.e. no notification/review/approval from the FDA is required)? ..Even so, though, the justification will be difficult, as technically the old ProCode still applies - it's just that the new one describes the device even more precisely.

 

[JeantheBigone]

My take on this (and of course my advice is worth what you're paying for it ) is that FDA has exempted both procodes, and therefore has decided that registration and listing ("General Controls") are sufficient to ensure safety and efficacy. FDA leaves it to manufacturers to self-assess and list as they see fit to be in compliance.

As a consequence, since neither procode requires a pre-market notification but only registration and listing, then all you need to do is register and list, ie deactivate the old listing and activate the new one. That is the only notification that FDA CDRH expects.

There is nothing stopping your company from maintaining GMP compliance, but FDA does not require or expect it, at least not for the time after the device was listed under a procode that is not GMP exempt.

If both procodes apply then all I see as necessary is that some record be made of why the original procode was chosen as opposed to the new one.