GMDN PT Codes vs. FDA Preferred Term (PT) Codes

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missjenny

Hello all,

For FDA GUDID, is there any reason why I should pay for a GMDN membership instead of using the freely available FDA PT Code?

One of my colleagues seems to think that FDA PT Codes are only temporarily available and we will all eventually have to acquire GMDN membership. I do not see where this is referenced anywhere in any of the FDA guidances.

Please advise!
 
S

SteveK

Re: GMDN PT Code vs. FDA PT Code

The three letter FDA Product Codes would seem to be rather fundamental i.e. for their MAUDE system, so I cannot see them being only temporarily available. GUDID supply the GMDN definition for a particular item on their site (though not the actual number). I do not know however if you have to supply the particular GMDN for your product so that GUDID can give the correct definition.

Steve
 
M

missjenny

Re: GMDN PT Code vs. FDA PT Code

Thank you for taking the time to read and respond to my question.

I understand that Product Codes are here to stay. What my colleague was referring to were the FDA Preferred Terms that are used in place of GMDN codes on the GUDID at the moment. My colleague is insisting that he has heard that the Preferred Terms are temporary and that the FDA itself has and continues to encourage manufacturers to become a GMDN member and use GMDN codes.

Does anyone know anything about this?
 
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TroutBrook

Re: GMDN PT Code vs. FDA PT Code

Hi MissJenny,

I'm not 100% sure FDA's long term position on this, but you may want to check out the proposed rule...quoting:

(12) The GMDN code for the device. GMDN is a comprehensive system of generic descriptors (preferred terms) with definitions used to generically identify medical devices. The main purpose of the GMDN is to provide regulatory authorities and other users with a single naming system that will support patient safety by facilitating data exchange between regulatory authorities, including the exchange of post-market surveillance information. We believe that the use of GMDN in the UDI Database would facilitate the organization of the database and allow users to quickly and efficiently search the database. At this time GMDN data is not available to the public unless a fee is paid to the GMDN Agency. We believe, however, that by the time we publish a final rule, GMDN data will be available to the public at no cost. We will not include this requirement in our final rule if GMDN data is not freely available by the time we publish a final rule.


So sounds like FDA didn't want people to have to use a for pay system (not sure why...they have no problem collecting fees!!)

Also, if you are selling globally, I've noticed that the new device regulations in Europe address this topic. Refer to article 21a of draft IVD reg where it talks about commission ensuring that medical device nomenclature shall be available free of charge.

When I look at all this together, I'm thinking either GMDN will become free of charge (as FDA hoped in proposed rule) or FDA terms will stay.
 
Q

QA-Man

Here's How to get GMDN codes.

Here's How to get GMDN codes.

Search the Australian Register of Therapeutic Goods (ARTG) for similar devices. Open the public ARTG summary pdf and you'll find the GMDN code at the bottom. Don't just check one product, as the code can be incorrect or there may be a more refined code that better describes your device.

There appears to be some differences between the GMDN PT and FDA PT. In more than one instance I used the FDA preferred term code because the equivalent GMDN code was made obsolete.
 
M

missjenny

Re: GMDN PT Code vs. FDA PT Code

TroutBrook

Thank you so much for your helpful reply!

I did not think to read the FDA Final Rule as I had been stuck on the guidances only. I suppose the Final Rule is legally binding while the guidances are only supplemental in nature.

Since the EU is also planning to make nomenclature freely available, I do not see why I should pay 2~3k a year for GMDN services.
:thanx:
 
T

T.J.

Has anyone seen an update related to this ruling with regards to nomenclature availability by the FDA or EU regulators?
 
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