Hi Lena,
Thank you for your response. Interesting question and I have tried to explain it to FDA in my emails. I did initially set up a pre-production account and then later realized that we were not required to do that unless we were using the HL7 SPL submission method. We are using web interface so there was no testing required. I mentioned that in my emails requesting production account access and I have submitted the form with no success. Two weeks is understandable to wait, but 2 months is a bit much especially when we are trying to meet timelines set by FDA.
Thank you for your input, I appreciate it. Maybe I will just submit a whole new form again and try like it's my first request.
Samantha Duffy | Regulatory Affairs / Compliance Manager | www.lsisolutions.com
LSI SOLUTIONS® | 7796 Victor-Mendon Rd. | Victor, NY 14564
T: 585.869.6699 | F: 585.742.1039 | E: sduffy@lsisolutions.com
image001.png@01CA3DD2.27FABA10">
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Original Message------
It takes about two weeks to receive a response back from the GUDID for the production account (even for a request submitted in mid-August). Did you submit a report with test evidence for the six scenarios described by the FDA in "GUDID HL7 SPL Submissions - Testing Requirement for Production Submission" (assuming you are doing electronic submissions rather than manual entry)? Whether you are entering manually or electronically, the "FDA Global Unique Device Identification Database (GUDID) New Account Request" form needs to be submitted. Is this the form you have sent it?
Regards,
------------------------------
Lena Cordie
Qualitas Professional Services
Watertown MN
United States
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Original Message:
Sent: 10-01-2015 09:51
From: Samantha Duffy
Subject: Access to GUDID Production Database
Hi Everyone,
I was wondering if others are having trouble getting FDA to provide access to the production accounts of the GUDID database? I have sent in the form several times since early August with no response to providing access. I've emailed the GUDID support staff asking them if I've submitted something incorrectly, but have not heard back. I'm starting to worry that my data will not be entered on time. Any suggestions? Are others having the same problem?
Thank You,
Samantha Duffy | Regulatory Affairs / Compliance Manager | www.lsisolutions.com
LSI SOLUTIONS® | 7796 Victor-Mendon Rd. | Victor, NY 14564
T: 585.869.6699 | F: 585.742.1039 | E: sduffy@lsisolutions.com
image001.png@01CA3DD2.27FABA10" width="184" height="23" border="0">
Confidentiality Notice: This e-mail and any files transmitted with it are private and confidential and are solely for the use of the addressee. It may contain material that is legally privileged. If you are not the addressee or the person responsible for delivering to the addressee, be advised that you have received this e-mail in error and that any use of it is strictly prohibited. If you believe you are not the intended recipient for this e-mail, please notify the sender.