FDA has just released the forms for "Small Business Qualification and Certification"

[Pads38]

FDA has just released the forms for "Small Business Qualification and Certification" for the tax year commencing 30th September 2016.

See here:-
(broken link removed)

(Small business = <100million turnover; qualification means much lower application fees).

On a related note - the application form needs to be countersigned by your relevant national tax authority.
In the UK this will be HMRC.
Does anyone know which HMRC office to contact for this purpose?

 

[Stijloor]

Re: FDA has just released the forms for "Small Business Qualification and Certificati

A Quick Bump!

Can someone help?

Thank you very much!

 

[welshwoman]

Re: FDA has just released the forms for "Small Business Qualification and Certificati

PADS38 Did you find out the answer to this. I am just going through the same process as I type!! Any help to locate the HMRC office relevant to completing Section III would be much appreciated and also is there a cost for them to do this do you know. I assume by now you have had your form completed?? Many thanks in advance.

 

[Pads38]

Re: FDA has just released the forms for "Small Business Qualification and Certificati

I failed to get any response from the HMRC. I tried the address in Cardiff that I had previously used successfully and, also, a direct e-mail.

IIRC this was requests to 'Large and Complex' business units - for a Small Business determination!

However, we have an affiliated company who applied, using a different contact and were successful. As the new (US) tax year has just started I will have another go and if I find the right contact I will update here.

 

[Mark Meer]

Re: FDA has just released the forms for "Small Business Qualification and Certificati

I'm having the same difficulty. Almost impossible to find someone from our "National Taxing Authority" who can sign the form.

 

[welshwoman]

Re: FDA has just released the forms for "Small Business Qualification and Certificati

I have actually just been informed by our US FDA Agent that the reduction in fees does not apply to medical device companies for renewal of registration address so unless someone can tell me otherwise we will have to pay the full fee, which is staggering for a small company!

 

[DEVigil]

Re: FDA has just released the forms for "Small Business Qualification and Certificati

It does not apply to the establishment registration fee. See page 6 of the Guidance document https://www.fda.gov/downloads/Medic...onandGuidance/GuidanceDocuments/UCM456779.pdf. It allows for discounts to various other filing fees (e.g., 510(k), PMA, etc.).