Regulatory Open Forum

Good morning,

I would like to know if anyone has completed the GUDID account request form and could share the experience. I am in the process of filling the form, but I am a little confused with the following:

1- FDA premarket application number:

- We are the labeler of several products, which application number should I use?  

- Should I create an account for each product?

2- How do I make the correlation of account and the different products we will be labeling?

Thank you so much for your help,

Valeria

Hi Valeria,

You only ned to submit the account request once and can list a couple of different application numbers or even just one. I think all they want to see is that you have a cleared Class II product. It is a fairly simple process.

Cheers.

Ajay Bhatia

Good morning,

I would like to know if anyone has completed the GUDID account request form and could share the experience. I am in the process of filling the form, but I am a little confused with the following:

1- FDA premarket application number:

- We are the labeler of several products, which application number should I use?  

- Should I create an account for each product?

2- How do I make the correlation of account and the different products we will be labeling?

Thank you so much for your help,

Valeria

Hi Valeria,

I will say that you should submit your request right away... it took us almost two weeks to get an account after sending our request. Also, selecting the correct type of account you want is very important (pre-production for HL7 SPL or production account for manual entry). The two systems are completely separate and we ended up with the wrong account type the first time around. Make sure to specify your desired account type both in the application itself and in the email you send to the UDI Help Desk.

As Ajay stated, you only need to include one of your Class II 510(k) numbers. It's just for them to verify that you will need access to the system.

Hope that helps!

Good morning,

I would like to know if anyone has completed the GUDID account request form and could share the experience. I am in the process of filling the form, but I am a little confused with the following:

1- FDA premarket application number:

- We are the labeler of several products, which application number should I use?  

- Should I create an account for each product?

2- How do I make the correlation of account and the different products we will be labeling?

Thank you so much for your help,

Valeria