Regulatory Open Forum

Recently we have run into a snag with our annual request for Small Business Designation because the Japanese Tax Authority refuses to sign-off on the FDA Form 3602A nor will they put their refusal in writing. In speaking with the FDA personnel involved it seems this year we are not alone. I am curious as to who else has encountered this and how you dealt with it?

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Matthew Hull RAC

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We ran into this with Ireland.  It took us a while to finally get the document signed.  

In talking with FDA during the process, we were told to not worry about getting the form signed next time, just submit with tax documents with the form not authorized by Ireland.


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Melinda Smith MS, RAC, CBA
Woodstock GA
United States
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Original Message:
Sent: 06-Dec-2017 08:44
From: Matthew Hull
Subject: FDA SBD Requests

Recently we have run into a snag with our annual request for Small Business Designation because the Japanese Tax Authority refuses to sign-off on the FDA Form 3602A nor will they put their refusal in writing. In speaking with the FDA personnel involved it seems this year we are not alone. I am curious as to who else has encountered this and how you dealt with it?

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Matthew Hull RAC

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​We do not have to get signature from Japan but I can say that the speed at which the Australian government is addressing this form has significantly slowed over the last few years. And this year, we are now going onto 4 months awaiting signature and no indication as to when the signed form will come out of the abyss. As a small business, the new fee structure makes this a critical signature and it is frustrating as we have absolutely no ability to influence the process.

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Melanie Hess
VP, Regulatory Affairs
Osprey Medical
United States
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Original Message:
Sent: 06-Dec-2017 08:44
From: Matthew Hull
Subject: FDA SBD Requests

Recently we have run into a snag with our annual request for Small Business Designation because the Japanese Tax Authority refuses to sign-off on the FDA Form 3602A nor will they put their refusal in writing. In speaking with the FDA personnel involved it seems this year we are not alone. I am curious as to who else has encountered this and how you dealt with it?

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Matthew Hull RAC

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Also confirm that getting this formed by tax authorities or revenue services in other countries has become difficult.  As Melinda said, most times FDA accepts without the signature, but we have had Japanese clients not bother with SBDN anymore.  However, the cost of 510(k) application being 5x as much for normal fee is also challenging.

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Richard Vincins RAC
Vice President Regulatory Affairs
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Original Message:
Sent: 06-Dec-2017 08:44
From: Matthew Hull
Subject: FDA SBD Requests

Recently we have run into a snag with our annual request for Small Business Designation because the Japanese Tax Authority refuses to sign-off on the FDA Form 3602A nor will they put their refusal in writing. In speaking with the FDA personnel involved it seems this year we are not alone. I am curious as to who else has encountered this and how you dealt with it?

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Matthew Hull RAC

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