Enabling Your System for UDI Data Entry
After you install UDI, you must enable your system for initial data entry by doing the following:
1. Obtaining a DUNS number
2. Obtaining a digital certificate
3. Setting up a gateway account with the Food and Drug Administration (FDA)
4. Setting up a UDI account with the FDA
5. Setting up a local AS2 gateway to test your data
Obtaining a DUNS Number
To obtain a unique nine-digit DUNS number from Dun & Bradstreet, go to
http://fedgov.dnb.com/webform.
Obtaining a Digital Certificate
• The digital certificate must be an X.509 version 3 certificate.
• All data in the Issuer and Subject fields must be completed.
• The certificate must be valid for at least one year and no more than three years. The FDA recommends certificates that are valid for three years.
• A Class 1 Personal Identification certificate (also known as a Secure Email certificate) is the minimum requirement for a digital certificate for use with the FDA Electronic Submissions Gateway (ESG).
• The FDA supports Public Key Infrastructure (PKI) for securely trading submissions. You can establish your own PKI or outsource it to a third-party certificate authority (CA).
• Before you set up your gateway account and register as a transaction partner for the FDA ESG, send a letter of non-repudiation to authenticate your digital identity.
• For additional requirements, see the “Digital Certificates” and “Letters of Non-Repudiation Agreement” sections of the ESG website at
http://www.fda.gov/esg.
Setting Up a Gateway Account with the FDA
For additional instructions, see the “FDA ESG Web Interface Electronic Submissions” section of the ESG website at
http://www.fda.gov/esg.
2. The FDA provides you with a URL, user id, and password for the AS2 registration wizard. Follow the AS2 registration wizard to complete the registration process.
After you successfully set up a test account, the FDA sends an email to the address you provided during registration. This email indicates approval as a transaction partner and authorization to send a test submission.
3. Send a test submission to make sure that the submission process is working.
Setting Up a UDI Account with the FDA
2. The FDA UDI Help Desk responds with an email containing a form. Complete this form with your account creation details and return the form to the FDA UDI Help Desk.
The FDA UDI Help Desk processes your account creation request and contacts you with the account creation decision.
Setting Up a Local AS2 Gateway to Test Your Data
Configure your quality solution and AS2 gateway with the FDA registration results and digital certificate.
1. Implement an AS2 server to perform the submission to the FDA AS2 gateway and to process the acknowledgements.
2. Optionally, in Windchill, change the file drop location. The Unique Device Identification module uses file drop functionality to create the HL7 message to be processed by the AS2 server and sent to the gateway. Acknowledgements returned to the AS2 server must be written to files to be picked up by the file drop function.
The default folder configuration is in the Windchill temp directory $(wt.temp) in filedropfdacommunications\<location>, where <location> is out, in, or orphan.
If a change is needed to this path, update the QMS.fdacommunicationfiledrop.properties.xconf file. This configuration file has five entries:
a. An outbox location for outgoing HL7 messages.
b. An inbox location of incoming acknowledgements from the FDA.
c. An orphan location for incoming acknowledgements from the FDA that cannot be linked to a previous communication.
d. A targz location. The files for UDI submissions are packaged in a tar.gz format.
e. A fileDropWaitTime entry. This property is the wait time to check the files in the directories for processing.
3. Test your UDI submission data. Any type of data can be submitted for your testing because the data is loaded only in the test database.
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The above instructions apply for a standalone setup. For a clustered environment, configuration of the AS2 gateway depends on the infrastructure set up in your organization. Make sure that the AS2 server setup supports the file drop protocol explained in the above instructions.
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Setting Up Preferences in the Preference Management Utility
In Windchill, configure the preferences for sending UDI submissions.
1. From the
Navigator, click the quality icon
for your quality context.
2. Click > .
3. Under the Quality section, right-click FDA Manufacturer Registration Number and select Set Preference. In the Value field, enter the FDA manufacturer registration number for your company and click OK.
4. Under the Quality section, right-click FDA UDI Submission - Submitter DUNS and select Set Preference. In the Value field, enter the DUNS number and click OK.
5. Update the other UDI preferences as needed.
| The following preferences are not applicable on UDI super set object types. a. FDA Manufacturer Registration Number b. FDA UDI Submission - Submitter Type c. UDI - FDA Listing Number - Read Only d. UDI - FDA Product Code - Read Only e. UDI - Premarket Authorization Number |
