FDI Device Package Registrations will be accepted provided the device (device type, device revision) is already Compliance Registered.
- A manufacturer may submit a device and FDI Device Package for registration simultaneously.
- Devices are tested first, if it meets the requirements for registration the FDI Device Package is tested.
FDI Device Package Revisions will be accepted for Registration in the FDI Device Package Library provided that an FDI Device Package for that device type and device revision is already registered.
- Updates made to FDI Device Packages must comply with the individual protocol compatibility rules.
- Any revision that would indicate a firmware change to the device will fail FDI Device Package registration. The device revision number must increase. The device must be tested and registered before the FDI Package is submitted.
What needs to be submitted?
Payment is accepted via purchase order or credit card authorization.
Each FDI Device Package submission must include payment for the fee.
The FDI Device Package must be tested with a live device.
FDI Device Package
Please see PD10028 for protocol specific requirements.
Where do I submit?
Each FDI Device Package is submitted as a separate ticket. The ticket serves as the application for testing and the test campaign historian.
Please open a new support request and specify the following:
Requester: Your email address
Company Name: Your company name
I need assistance with: Product Registration Details: FDI Device Package Additional Details: (select a Protocol)
Subject: Model Name (i.e. Pressure100T)
Details: A short description
Attachments: Please attach the purchase order
You will receive a summary of the test campaign and a link to download the latest Registration Kit via email. Please upload completed forms and FDI Device Package to the ShareFile link provided in the email from the support ticket system.
Where do I send my device?
Please see the Registration Kit, Device Shipping Instructions. Device hardware must be sent to our Austin, Texas, USA facility.