Regulatory Open Forum

Hello. I've carefully reviewed the FDA website regarding GUDID and am not sure when my client would request a GUDID account because we are still a couple of months away from submitting their 510(k) for Class II medical device. Can they go ahead and request the account now as I know it can take time and should they get it before their device gets clearance just sit on it and not enter any device UDI information? Any advice would be greatly appreciated!

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Susan Bush
CEO
Shamong NJ
United States
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I recently came across a similar situation. I worked with a company that was preparing a submission but was not aware of the UDI rule. They did not have a GUDID account.  Because they were still months if not a year away from commercializing their product in the US, they did not have to submit UDI info yet.  The UDI is required once the product is in commercial distribution in the US; otherwise they can wait.

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Karen Zhou
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Original Message:
Sent: 10-Jan-2019 15:21
From: Susan Bush
Subject: When to request GUDID account

Hello. I've carefully reviewed the FDA website regarding GUDID and am not sure when my client would request a GUDID account because we are still a couple of months away from submitting their 510(k) for Class II medical device. Can they go ahead and request the account now as I know it can take time and should they get it before their device gets clearance just sit on it and not enter any device UDI information? Any advice would be greatly appreciated!

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Susan Bush
CEO
Shamong NJ
United States
------------------------------

Yes, a GUDID account can exist with data not yet entered. After it's set up, it will let you practice ​entering data in draft form without submitting it, although the drafts will be automatically deleted after a period of time. And yes, it does take some time to set up an account, so it's best not to wait until the last minute. But you may have to wait for a while anyhow, considering the current shutdown. In the meantime, you can refer to the GUDID Data Elements Reference Table to figure out what sort of data you'll be entering when it's all ready.

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Anne LeBlanc
Manager, Regulatory Affairs
United States
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Original Message:
Sent: 10-Jan-2019 16:21
From: Karen Zhou
Subject: When to request GUDID account

I recently came across a similar situation. I worked with a company that was preparing a submission but was not aware of the UDI rule. They did not have a GUDID account.  Because they were still months if not a year away from commercializing their product in the US, they did not have to submit UDI info yet.  The UDI is required once the product is in commercial distribution in the US; otherwise they can wait.

------------------------------
Karen Zhou

Original Message:
Sent: 10-Jan-2019 15:21
From: Susan Bush
Subject: When to request GUDID account

Hello. I've carefully reviewed the FDA website regarding GUDID and am not sure when my client would request a GUDID account because we are still a couple of months away from submitting their 510(k) for Class II medical device. Can they go ahead and request the account now as I know it can take time and should they get it before their device gets clearance just sit on it and not enter any device UDI information? Any advice would be greatly appreciated!

------------------------------
Susan Bush
CEO
Shamong NJ
United States
------------------------------

I concur with Anne that you can set up a GUDID account in advance of putting in the information that you can "practice" entering information.  It is a good idea to set up in advance of the clearance or approval so when you do need to enter information it is done.

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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 11-Jan-2019 12:30
From: Anne LeBlanc
Subject: When to request GUDID account

Yes, a GUDID account can exist with data not yet entered. After it's set up, it will let you practice ​entering data in draft form without submitting it, although the drafts will be automatically deleted after a period of time. And yes, it does take some time to set up an account, so it's best not to wait until the last minute. But you may have to wait for a while anyhow, considering the current shutdown. In the meantime, you can refer to the GUDID Data Elements Reference Table to figure out what sort of data you'll be entering when it's all ready.

------------------------------
Anne LeBlanc
Manager, Regulatory Affairs
United States

Original Message:
Sent: 10-Jan-2019 16:21
From: Karen Zhou
Subject: When to request GUDID account

I recently came across a similar situation. I worked with a company that was preparing a submission but was not aware of the UDI rule. They did not have a GUDID account.  Because they were still months if not a year away from commercializing their product in the US, they did not have to submit UDI info yet.  The UDI is required once the product is in commercial distribution in the US; otherwise they can wait.

------------------------------
Karen Zhou

Original Message:
Sent: 10-Jan-2019 15:21
From: Susan Bush
Subject: When to request GUDID account

Hello. I've carefully reviewed the FDA website regarding GUDID and am not sure when my client would request a GUDID account because we are still a couple of months away from submitting their 510(k) for Class II medical device. Can they go ahead and request the account now as I know it can take time and should they get it before their device gets clearance just sit on it and not enter any device UDI information? Any advice would be greatly appreciated!

------------------------------
Susan Bush
CEO
Shamong NJ
United States
------------------------------

There is absolutely no issue in having a GUDID account prior to a commercial release of your product. As Anne and Richard had mentioned, you can prepare a draft DI record of the desired product in the database so that you know what is required for its submission. If you have accurate information regarding your product, you can save it as a draft until your product gets ready for commercial release. You can create and delete as many drafts as you want. But once a DI record is published, it is permanent and no changes are allowed after the grace period (7 calendar days after publishing).

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Phani Puppala
Franklin MA
United States
------------------------------

Original Message:
Sent: 10-Jan-2019 15:21
From: Susan Bush
Subject: When to request GUDID account

Hello. I've carefully reviewed the FDA website regarding GUDID and am not sure when my client would request a GUDID account because we are still a couple of months away from submitting their 510(k) for Class II medical device. Can they go ahead and request the account now as I know it can take time and should they get it before their device gets clearance just sit on it and not enter any device UDI information? Any advice would be greatly appreciated!

------------------------------
Susan Bush
CEO
Shamong NJ
United States
------------------------------

Good morning RAPS members. Thank you to everyone who replied- greatly appreciated!

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Susan Bush
CEO
Shamong NJ
United States
------------------------------

Original Message:
Sent: 14-Jan-2019 14:52
From: Phani Puppala
Subject: When to request GUDID account

There is absolutely no issue in having a GUDID account prior to a commercial release of your product. As Anne and Richard had mentioned, you can prepare a draft DI record of the desired product in the database so that you know what is required for its submission. If you have accurate information regarding your product, you can save it as a draft until your product gets ready for commercial release. You can create and delete as many drafts as you want. But once a DI record is published, it is permanent and no changes are allowed after the grace period (7 calendar days after publishing).

------------------------------
Phani Puppala
Franklin MA
United States

Original Message:
Sent: 10-Jan-2019 15:21
From: Susan Bush
Subject: When to request GUDID account

Hello. I've carefully reviewed the FDA website regarding GUDID and am not sure when my client would request a GUDID account because we are still a couple of months away from submitting their 510(k) for Class II medical device. Can they go ahead and request the account now as I know it can take time and should they get it before their device gets clearance just sit on it and not enter any device UDI information? Any advice would be greatly appreciated!

------------------------------
Susan Bush
CEO
Shamong NJ
United States
------------------------------

I contacted FDA's UDI Help Desk back in July, asking about applying for an account *before* receiving clearance, and was specifically told by FDA that:

"... you will need to either submit a premarket number for an approved device for which you are required to submit data to GUDID, or wait until your device is approved to contact us again. GUDID is for FDA approved or cleared devices."

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Matt Dodd
Regulatory Affairs Specialist
Cambridge
United Kingdom
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Original Message:
Sent: 10-Jan-2019 15:21
From: Susan Bush
Subject: When to request GUDID account

Hello. I've carefully reviewed the FDA website regarding GUDID and am not sure when my client would request a GUDID account because we are still a couple of months away from submitting their 510(k) for Class II medical device. Can they go ahead and request the account now as I know it can take time and should they get it before their device gets clearance just sit on it and not enter any device UDI information? Any advice would be greatly appreciated!

------------------------------
Susan Bush
CEO
Shamong NJ
United States
------------------------------