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

#1
FDA has just released the forms for "Small Business Qualification and Certification" for the tax year commencing 30th September 2016.

See here:-
http://www.fda.gov/downloads/Medica...p;utm_medium=email&utm_source=govdelivery

(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?
 
Elsmar Forum Sponsor

Stijloor

Staff member
Super Moderator
#2
Re: FDA has just released the forms for "Small Business Qualification and Certificati

A Quick Bump!

Can someone help?

Thank you very much!
 
W

welshwoman

#3
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.
 
#4
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

Trusted Information Resource
#5
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. :(
 
W

welshwoman

#6
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!
 
Thread starter Similar threads Forum Replies Date
D FDA Biomarker Qualification Program - Has anyone prepared an application? Medical Device and FDA Regulations and Standards News 0
lilybef FDA and Biocompatability Testing - Reviewer has requested implantation testing Other Medical Device Related Standards 11
M FDA News FDA Report - FDA Has Taken Steps to Strengthen The 510(k) Program Other US Medical Device Regulations 0
B FDA Philippines has no check or balance outside the health department Supplier Quality Assurance and other Supplier Issues 3
Z Has FDA reclassified Electroconvulsive Therapy (ECT)? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
M Has anyone had their electronic system scrutinized in an FDA inspection? Records and Data - Quality, Legal and Other Evidence 16
B Has FDA amended any standards in the 21 CFR Part 800 series? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
N Has the FDA approved Electron Beam for Sterilization of bottles? US Food and Drug Administration (FDA) 1
E Every US state has Medical Device Regulations beside FDA Regulations Other US Medical Device Regulations 11
AnaMariaVR2 FDA has issued three Warning Letters... US Food and Drug Administration (FDA) 13
D Has anyone used ExtraView software in FDA regulated industry? Qualification and Validation (including 21 CFR Part 11) 3
A 510(k) Screening Checklist that the RA has filled out - Is that sheet for FDA use? ISO 13485:2016 - Medical Device Quality Management Systems 2
B Has anyone ever had to submit a DMF (Drug Master File) with the FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
Marc FDA has auditing guidelines posted on it's web pages for QSR ISO 13485:2016 - Medical Device Quality Management Systems 3
M FDA Medical device reporting (Manufacturer in US; contract manufacturer OuS) US Food and Drug Administration (FDA) 0
JesseE Electronic signatures FDA CFR 820 ISO 13485:2016 - Medical Device Quality Management Systems 3
C FDA logo for marketing US Food and Drug Administration (FDA) 3
G FDA clearance for a device that can't be used clinically (at present) Other US Medical Device Regulations 5
M FDA Syringe Marking requirements US Food and Drug Administration (FDA) 4
K Guidance on X-Ray Medical Devices for Animal Use - FDA US Food and Drug Administration (FDA) 0
S FDA 510(K) submission question US Food and Drug Administration (FDA) 4
T FDA UDI Question - Class II Medical Device Other US Medical Device Regulations 1
P Does FDA require certification for quality system internal audit for auditor? Qualification and Validation (including 21 CFR Part 11) 1
I If i do not want to be an initial importer should i register with FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
B When FDA Decision Summary opens? US Food and Drug Administration (FDA) 4
Ed Panek FDA Remote Regulatory Assessment (RRA) Overview 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
B What is the difference btw RUO vs IUO for IVD in FDA guidance ? US Food and Drug Administration (FDA) 12
B How to submit Pre-submission to FDA? US Food and Drug Administration (FDA) 4
L FDA & 21 CFR Part 11 Medical Device and FDA Regulations and Standards News 19
B A.I. diagnostic software is considered as medical device in FDA? US Food and Drug Administration (FDA) 6
Ed Panek 2020 FDA Top Ten Observations 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
M FDA Requirements for Investigational Devices - Clinical Investigation & Shipping Medical Device and FDA Regulations and Standards News 0
Ed Panek Does this FDA Requirement Apply to international (not USA) distributors for USA based manufacturing companies? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
B FDA Breakthrough Device can be overlapped with a designated device? US Food and Drug Administration (FDA) 6
pbojsen ISO 13485 Requirements versus FDA product classification and GMP exemptions - Audits ISO 13485:2016 - Medical Device Quality Management Systems 5
S Examples of FDA acceptable Software Design Specification (SDS) Medical Device and FDA Regulations and Standards News 6
F Labelling to comply with both FDA and MDR US Food and Drug Administration (FDA) 6
Watchcat FDA vs NB Fees? Other US Medical Device Regulations 7
K FDA Registration and listing weird situation Medical Device and FDA Regulations and Standards News 4
D FDA Guidance on Computer Software Assurance versus 21 CFR Part 11 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
G Does FDA allows remote approvals of quality documentation. Is there any specific guidance on signing any quality records remotely? Document Control Systems, Procedures, Forms and Templates 1
B Does FDA Registration QSR need to cover non-medical devices for contract repackager? US Food and Drug Administration (FDA) 1
C Non-sterile reusable surgical instruments - FDA sterilization requirement Other Medical Device Related Standards 2
D FDA Information - Revising the Instructions for Use US Food and Drug Administration (FDA) 0
S Transitional Adolescent A and B - "CDRH PREMARKET REVIEW SUBMISSION COVER SHEET FORM FDA 3514" Medical Device and FDA Regulations and Standards News 1
B FDA requirement for CAPA Signoff ISO 13485:2016 - Medical Device Quality Management Systems 6
P MSDS for MVQ FDA White, Vinyl Methyl Silicone Rubber EU Medical Device Regulations 4
S Manufacturing Process FDA FOIA Medical Device and FDA Regulations and Standards News 3
S Manufacturing Process FDA FOIA US Food and Drug Administration (FDA) 4
S Mechanical Test Under FDA Freedom of Information Act Medical Device and FDA Regulations and Standards News 5

Similar threads

Top Bottom