Yeah hey Jude, seems like these guys have you in good shape, but there is an eSubmitter software you can download and after that you should he able to directly access the gateway from your desktop. But once inside, you can select the option for FDA form 3500A.

If you also need help with assigning any of the codes associated with any MDR, let…

Read more

Hi Jude, happy to help as well. Here is a link to the FDA’s page for the ESG NextGen:

https://www.fda.gov/industry/electronic-submissions-gateway-next-generation-esg-nextgen/getting-started-esg-nextgen

If you have additional questions or want further pointers, please reach out directly.

fda.gov

Getting Started with ESG NextGen

Getting Started with ESG NextGen

Hi Jude. Yes, I can help you out – let’s connect directly!

Hey Holly, sorry, I meant the metrological traceability section. No screen shot, we don’t have any verbiage for it yet.

It is a standalone control used to verify calibration of clinical lab equipment. The NB seems to want to see metrological traceability back to the original control material or some statement to that effect in the IFU.

Hi Ash, also not sure if you intended to include any type of screenshot or anything but what specifically in the IFU were they pushing back on? Thanks!

Hi Ash can you be more specific as to what on the Medical Device requires Metrological Traceability ?