Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi,

We are a small company who submitted its first 510(k).
The 510(k) is under review. Can we request GUDID account while the 510(k) is under review or shall we wait for a clearance before submitting a GUDID account creation request?

Can someone please also guide on the Web Interface and the HL7 SPL submission. I read it, however, did not really understood it. As I understand companies with less number of products should go Web Interface way. 

Thanks in advance for the help!

For a single product, definitely use the web interface. You just go online, log in, and type in your information. To use the HL7 option, you would have to write and validate some software to let your database talk to their database -- only worth the effort if you have a lot of data to manage.

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

Original Message:
Sent: 19-Jul-2019 12:02
From: Anonymous Member
Subject: GUDID account request

This message was posted by a user wishing to remain anonymous

Hi,

We are a small company who submitted its first 510(k).
The 510(k) is under review. Can we request GUDID account while the 510(k) is under review or shall we wait for a clearance before submitting a GUDID account creation request?

Can someone please also guide on the Web Interface and the HL7 SPL submission. I read it, however, did not really understood it. As I understand companies with less number of products should go Web Interface way.

Thanks in advance for the help!

If you have less than 100 or so SKUs (bar codes, DIs) just use the web interface as Anne indicated since once set up does not take much to enter the data.  Definitely if you have less than 10 part numbers the web interface is the easiest.  In order to enter in the GUDID you need to wait until the 510(k) is cleared and maybe even a couple weeks until FDA's internal database is updated and synced.  You have to put in the 510(k0 number in the GUDID so it will not register if the device is not yet cleared because it looks up on the 510(k) database.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 19-Jul-2019 23:43
From: Anne LeBlanc
Subject: GUDID account request

For a single product, definitely use the web interface. You just go online, log in, and type in your information. To use the HL7 option, you would have to write and validate some software to let your database talk to their database -- only worth the effort if you have a lot of data to manage.

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

Original Message:
Sent: 19-Jul-2019 12:02
From: Anonymous Member
Subject: GUDID account request

This message was posted by a user wishing to remain anonymous

Hi,

We are a small company who submitted its first 510(k).
The 510(k) is under review. Can we request GUDID account while the 510(k) is under review or shall we wait for a clearance before submitting a GUDID account creation request?

Can someone please also guide on the Web Interface and the HL7 SPL submission. I read it, however, did not really understood it. As I understand companies with less number of products should go Web Interface way.

Thanks in advance for the help!