Any experience on filling form, FDA 3654 for the DICOM standard?


Involved In Discussions
How have you handled filling out form 3654 for the DICOM standard? It's HUGE and we do not cover every modality and option. But, we do adhere to the standard file format and rules. How have you filled this out (and passed the submission) for the DICOM standard?

Can I refer to our conformance statement?

Thank you!


Re: Fill out FDA 3654 for the DICOM standard?

The form is generic and is only two pages long.
Complete this as you would for any other applied standard.


Involved In Discussions
I get that it's generic but that is what's making it more difficult. I've looked for guidance and NEMA has it on their agenda to create guidance but there is none yet. I need to fill out the form this week.

If anyone else has filled out 3654 for DICOM, please let me know how you addressed what you adhered to and what you did not.
Top Bottom