Link GMDN code and FDA product code

TomQA

Starting to get Involved
#1
Hello,

We are considering the registration of our medical device in the US and I am struggling to find the FDA product code.
Our medical device has the GMDN code 60702 and I was therefore wondering if there was a possibility fo find a corresponding FDA product code thanks to the GMDN code?
Thank you !
 
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mihzago

Trusted Information Resource
#2
What registration are you trying to perform? Are you looking for a predicate device to submit a 510(k), or are you trying to register the device with the GUDID?
GMDN codes do not correspond to the FDA Product Classification Codes; however, GUDID database uses GMDN terms but the numbering is not the same.
What device is GMDN code 60702?
 

TomQA

Starting to get Involved
#3
Hi, thanks for your response.
Basically I would like to know the product code to know the classification of the device.
The device's description with the GMDN code 60702 is the following :
"An application software program designed as an Internet-based information system to support the administrative, clinical, and quality control activities associated with the provision/utilization of healthcare within a specific clinical specialty (neurology). It can be available on any web-enabled interface (including mobile devices at point-of-care) and is intended for use by healthcare professionals in a clinical setting. (definition of the GMDN code."
Basically the device is a software/webapp/platform for the therapist to plan the therapy sessions for the patient which uses a medical device with product code QKC.
 

TomQA

Starting to get Involved
#5
Yes this device we already know (Device B let's call it).
I am trying to find the product code of Device A that is used to create a therapy plan for a patient which used Device B.
Device A is an accessory to Device B
 

mihzago

Trusted Information Resource
#6
It's quite possible it fits within the same product code as the parent device.
There are usually limits to exemptions, so if for example the app to create the therapy plan does it automatically without clinician input based on information it collects from the parent device, then you may have to consider submitting a 510(k).
 
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