Small Business Qualification Certification Submission - FDA Form 3602

[InerQuaSurg]

I'm currently in the process of submitting FDA Form 3602 but, I haven't been able to locate any guidance from FDA on what to submit, if anything, for a start-up company with no prior year income tax return. Can anyone help with a little guidance? Thanks!

 

[J0anne]

It's a long time since I completed one of these so I can't say for sure. But I do know that once you have sent the form, it takes a very long time to get a response. Therefore my my advice is to give them a call on 001-800-638-2041 or 001-301-796-7100 and make sure you get things absolutely correct before you send it to them.

 

[InerQuaSurg]

Yeah, they can be quite the stciklers! Thanks

 

[J0anne]

You're welcome, but from memory, I don't believe the FDA did anything to hold it up. I think it was something to do with the tax office.

 

[InerQuaSurg]

You're welcome, but from memory, I don't believe the FDA did anything to hold it up. I think it was something to do with the tax office.

According to the guidance on their website, they have a 60 day review period and must give you a response within that time frame but, that's assuming you've submitted all the correct docs. I've got multiple emails in to different departments there however, the Division of Industry and Consumer Education (DICE) doesn't take phone calls and has the "prompt" response time of 2-3 days via email. Hopefully they'll get back to me with some helpful information.

 

[Bonebuilder]

I'm currently in the process of submitting FDA Form 3602 but, I haven't been able to locate any guidance from FDA on what to submit, if anything, for a start-up company with no prior year income tax return. Can anyone help with a little guidance? Thanks!

Hi

I don't know if its the same for you guy's domestically but as an overseas Small Business we faced the problem with a start up project that because we we're effectively not trading and therefore hadn't submitted any accounts to the UK tax office they couldn't provide us a certificate confirming that we were a qualifying small business....! Bit of a catch 22 really.

As to guidance take a look at this link on the FDA site;

http://www.fda.gov/downloads/Medica...onandGuidance/Overview/MDUFAIII/UCM314389.pdf

Good luck, I'll watch with interest