The FDA Registration process

I had the privilege of starting the FDA registration process recently for a tobacco client and thought it worth sharing my experiences.

All the information on what needs to be done including a check list is available on the FDA website. This is helpful; at least there’s a template to work from.

What’s missing is exactly how to do it. There’s a lot of detail and you must pay particular attention to the sequence.

The tricky part is obtaining the personal digital certificate. If you don’t have (much / any) experience with digital certificates and signatures this part will turn you for a loop. Nothing (with FDA) can be done without it!

On the FDA website there is a list of digital signature providers and links to their websites. One is free – all the others want money and in some cases quite a bit.

Assuming the correspondence for letters of non-repudiation has also been sent – and is correct, you wil receive a reply from FDA. You can then start setting up your (WebTrader) test account. Essentially you are verifying the communication link – to FDA – and exchanging parts of the digital certificates with FDA which allows your data to be identified as uniquely yours and FDA to receive encrypted secure data.

So far so good.

After this you receive further notifications from FDA and then make a second test submission. If this all goes well…………….you can set up a Production Account.

Remember up until now no data has been exchanged. More on this later.

If you haven’t started the process I encourage you to get going – the registration deadline is February 28 and there are other deadlines looming in April and June.

Enjoy.

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