Updated on November 17, 2020

 


FDI Device Package Registration Timeline and Requirement Update 

TSB ID:

FCG.TS/20201019066/TSB 

Product Line:

FDI 

Affected Product(s): 

Registration Services 

Scope:

Policy Update 

Effective Date:

January 1, 2021 

 

Dear Members,

Thank you for your continued support of FDI technology.

Beginning on January 1, 2021 FieldComm Group registration policies will require that devices submitted for registration include FDI Device Packages.

FieldComm Group recognizes that our member device suppliers, who are in the process of building FDI Device Packages, may be affected due to the FDI specification revision. These specification changes reflect clarifications and enhancements associated with UID layout; specifically, “unit conversion”, “label length” and “optimized layout”. Details of these changes will be published as “Interpretation Resolution” to the membership before the end of the year and then balloted to become a specification revision, estimated to be complete by 31 March 2021. In addition, the change will be incorporated into FDI Tools and Common Host Components by the same date.

 FCG is offering members the following:

  • Any device supplier may opt-out of the mandatory date of 1 January 2021 by notifying FCG that they will need additional time to be compliant due to this change and receive an exception to the date, allowing them to register their devices without a package between now and the extended deadline of 1 October 2021.
     
  • In an effort to prioritize and encourage FDI Device Packages to be developed for new devices, any devices submitted for re-registration that were registered prior to 31 December 2017 are not required to have an accompanying device package for its re-registration until 1 January 2022.

 


Questions

 

1. FDI Specification clarifications and enhancements associated with UID layout, unit conversions, and upload/download are being made. Do these clarifications and enhancements impact the requirement to deliver an FDI Device Package on January 1, 2021?

 Yes, they do. Device developers have two options:

  1. Submit the FDI Device Package for registration as scheduled. If the package is non-compliant  with the specification changes, FCG will grant a registration exception valid through 1 October 2021.  At that time, a package revision must be submitted, at no charge, for re-registration.  If additional enhancements to the package are made with the submission, standard fees will apply. 
  2. Any device supplier may opt-out of the mandatory date of 1 January 2021 by notifying FCG that they will need additional time to be compliant due to this change and receive an exception to the date, allowing them to register their devices without a package between now and 1 October 2021.


NOTE :  For (i) above, FDI Device Packages are tested with current test specifications based on the current toolsets.  After the release of the updated v1.5 toolset, the FDI Package developer should submit an updated FDI Package to FieldComm Group to take advantage of new features highlighted by the Interpretation Resolutions.  All testing and registration fees will be waived for this 2nd test so long as the changes are restricted to the scope of those Interpretation Resolutions. Doing so assures that your package conforms to the latest specifications   To take advantage of this no-fee re-registration, the FDI Device Package must be re-submitted no later than 1 Jan 2022.


Alternatively, (ii), the FDI Device Package supplier can opt out of providing an FDI Device Package through 1 Oct 2021.  The offer of a complimentary re-registration is not offered under this scenario.


2. Does the requirement to submit FDI Device Packages include new devices, device revisions, and DD revisions?

New devices must be submitted with FDI Device Packages, with the exception outline in question 1. Re-registrations, including device revisions and DD revision, for devices last revised prior to 31 December 2017 are exempt from requiring FDI Device Packages until 1 January 2022.

If you have any questions about what is required for device, please issue a support ticket and we will clarify the requirement.


 
3. When am I required to provide an FDI Device Packages for product registration?

4. Are EDD-only registrations affected by this policy?

No. Members can continue to maintain existing registered EDDs where there are no changes to the product itself (i.e. existing device revisions).

Need additional information or have a question?
Please contact Tech Support 

Additional Questions
5. When will developers have all information to implement a conformant package to the new features?
All Interpretation Resolutions are planned for availability by 12/31/2020. At this point, developers will have all the necessary information for developing conforming products.

6. How will conformance testing change to test these features?
The FDI toolset planned for release in early 2021 will include full support for Optimized Layout for testing and development. FDI package testing will be updated to confirm the adjusted requirements. Manual inspection will be used where automation rules are not yet defined or cannot be readily applied.

7. My device is not currently scheduled for an update. Do I have to submit an FDI Package immediately regardless?
No, the FDI Package is expected upon your next submission. Please refer to the chart above in Q3 for applicable circumstances.