FDA 510(k) Payment requirements for a Small Company

A

Anoniem

#1
We are a small medical device company in the Netherlands. We want to start selling our devices around October this year in the USA.
Our 510(k) is finally finished for the major part of our products, composing this was a lot of work. It is boxed and ready for shipment.
I wanted to ship it and do the payment, so they receive the payment and the box at the same time, as is written on the FDA website.

Then I saw this:
FDA will not accept reduced fees without a Small Business Decision number and will not refund the difference between the standard fee and the small business fee after the submission has been received.


That Small Busines Decision number will take us max 6 weeks locally and 8 weeks for FDA, this is 2,5 months delay in our planning. :mg:

Except from paying the standard fee ($5,170 instead of $2,585), does anybody have a bright idea to speed this up?

I also want to warn other new small companies, organise this number before writing that 510(k)! FDA helpdesk has no other solution.

Thank you very much for your comments!
 
Elsmar Forum Sponsor
I

isoalchemist

#2
No good idea's. The FDA has enough problems keeping thing straight with payments under normal conditions.
 
A

ascherp

#3
We are consultants and have submitted many small business applications for our clients over the last few years. It is true that the FDA website establishes a turnaround time of 8 weeks, but our experience has been that it actually takes much less time if the forms are complete at the time of submission. Record time for the FDA to assign a small business number was five business days after receipt of the application and it has never taken more than two weeks.

Belasting may be more of a problem for you... Good luck!
 
A

Anoniem

#4
Thank you both for your response, I appreciate that. We decided to just continue the official procedure and keep our fingers crossed for a quick procedure!
 
Thread starter Similar threads Forum Replies Date
K Mammography Machine Bench Testing - FDA 510(K) US Food and Drug Administration (FDA) 5
M Informational US FDA Final Guidance – Special Premarket Notification [510(k)] Pathway Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Final guidance – Metal Expandable Biliary Stents – Premarket Notification (510(k)) Submissions Medical Device and FDA Regulations and Standards News 0
Watchcat Informational FDA Proposal to "Modernize" the 510(k) - 2019 Other US Medical Device Regulations 1
L A Taiwan company want to sell Class I medical device (510(k) exempt) on Amazon, should we register with FDA? US Food and Drug Administration (FDA) 4
S Where did FDA 510(K) form 3654 go? Other US Medical Device Regulations 4
M FDA News US FDA – November 2018 510(k) Clearances Medical Device and FDA Regulations and Standards News 0
M FDA News FDA Report - FDA Has Taken Steps to Strengthen The 510(k) Program Other US Medical Device Regulations 0
M Medical Device News FDA - Transformative new steps to modernize FDA’s 510(k) program to advance the review of the safety and effectiveness of medical devices Other US Medical Device Regulations 0
M Medical Device News FDA - Eliminating Routine FDA news 14-09-18 - Re-Review of Third Party 510(k) Reviews Other US Medical Device Regulations 0
M Medical Device News FDA News - 06-09-18 - FDA - Quality in 510(k) "Quik" Review Program Pilot Other US Medical Device Regulations 0
R FDA in 2018 - Obstructing and Over-regulating 510(k) Other US Medical Device Regulations 10
Q FDA:Expansion of the Abbreviated 510(k) 2 Program 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
F FDA PMK 510(k) - IEC 62304 Software Components Segregation Other US Medical Device Regulations 3
I FDA Exempts Product Codes from 510(k) Process (Class II Medical Devices) US Food and Drug Administration (FDA) 0
Ronen E FDA releases new draft guidance on when to submit a 510(k) for device modification Other US Medical Device Regulations 10
E FDA Consensus Standards in 510(k) - Declarations of Conformity US Food and Drug Administration (FDA) 3
K 510 (k) - Requirement to notify the FDA or is only the Notified Bodies required? Registrars and Notified Bodies 1
M New FDA Draft Guidance on 510(k) Ownership and Use Other US Medical Device Regulations 3
A FDA 510(k) Submission Timelines US Food and Drug Administration (FDA) 1
Ajit Basrur FDA issues Guidance Document - Benefits-Risks Factors to consider for 510(K) US Food and Drug Administration (FDA) 1
A Biocompatibility omission justification for FDA 510(k) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
M Demonstrating battery safety in 510(K) submission for the FDA Other US Medical Device Regulations 9
S FDA Draft Guidance on HLA Kits 510(k) Submission 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
D FDA 510(k) Submission Tests - Posterior Cervical Spinestem 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M What are FDA expectations regarding Standards referenced in the 510(k)? US Food and Drug Administration (FDA) 3
T Conformance Standards that the FDA recognizes for 510(k) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
R FDA 510(k) Cover Letter Contents US Food and Drug Administration (FDA) 2
A How do I inform FDA on discontinuation of 510(K) device ? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
Ronen E FDA distributes draft guidance related to X-ray Imaging Device 510(k)s Other US Medical Device Regulations 1
N New Actions for the FDA's 510(K) Program ISO 13485:2016 - Medical Device Quality Management Systems 0
Michael Malis FDA to release proposed 510(k) improvements today US Food and Drug Administration (FDA) 1
M Special 510(k) FDA experience? US Food and Drug Administration (FDA) 10
T IEC 62304:2006: Medical device software SDLC- CE Vs. Fda 510(k) submission IEC 62304 - Medical Device Software Life Cycle Processes 16
M Interested in improving the FDA 510(k) system? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
T Applying for FDA 510(k) for 21 CFR 892.2050 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
R FDA 510(k) Summary and FDA 510(k) Statement 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10
M FDA 510(k) Summary and FDA 510(k) Statement Differences 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
bio_subbu FDA Guidance document - User Fees and Refunds for 510(k) submissions 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
C The warning letter of ONBO - Why FDA require identification of 510(k) ownership? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
C FDA delaying notification of receipt of 510(k)'s - What wrong with FDA? - China US Food and Drug Administration (FDA) 3
C Will FDA check the 510(k) files in field inspection? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
C 510(k) Timing from Submittal to FDA Approval 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
C Australian Medical Device Database like the US FDA's 510(k) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
L Canada Medical Device Database like the US FDA's 510(k) Canada Medical Device Regulations 8
C Design control documentation provided in special 510(k) + FDA response 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
R FDA Under Pressure From Congress - Impact on pending 510(k)'s 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
W Can a CSA-US certificate substitute a FDA 510(k) clearance? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
C Application for special 510(k) - What are the documents to submit to FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
W 510(k) FDA Memorandum #k97-1 and S & E decisions 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5

Similar threads

Top Bottom