In this webinar, you will learn the process of applying for small business qualification and payment of the MDUFMA fee for a 510k submission.
Many small businesses don’t yet earn revenues, but if you are planning to submit a 510k you might want to file your taxes–even if you don’t need to. The new FDA user fees have been released and if your small business has a tax return you can save $7,924 if you submit your small business qualification application on October 1. Note: The above dollar amounts were effective in 2017 for FY 2018. Current pricing is reflected on our homepage.
Application Form for Small Business Qualification
The small business qualifications must be renewed each year, and most of the small businesses I work with fail to submit the form early enough in order to take advantage of this deduction or the companies have difficulty gathering the tax records required for the application. On August 27, the FDA released the new MDUFMA fees for FY 2018 — which begins October 1, 2017. If you are planning to submit a 510k after September 30, you will now be applying for FY 2018 small business status instead. A portion of the webinar will also explain what information is needed to complete the form and the requirements to be approved for small business status. You will also be sent a copy of the guidance document and application form along with the native slide deck for this webinar.
Payment Methods for the MDUFMA Fee
Once a company receives a small business qualification identification number, the company must enter its User Fee Account to create FDA Form 3601 in order to include it in Section 1 of the 510k submission. Form FDA 3601 is also submitted along with the physical payment of the user fee or the company must pay the fee electronically.
When is the Small Business Qualification Fee Webinar?
This webinar was recorded on Friday, September 8, 2017. Anyone purchasing this webinar will receive a recording of the webinar and a copy of the native slide deck for $19. The slide deck is 22 slides and the recording is approximately 18 minutes long–which is much less time than it will take you to read the 39-page guidance document. All deliveries of content will be sent via AWeber emails to confirmed subscribers.
Please submit questions to me by email at firstname.lastname@example.org regarding the Small Business Qualification Fee Webinar or call me at +1.802.281.4381.
Small Business Qualification Fee Webinar is available for $19.00.
In this webinar you will learn the different payment methods for a 510k submission and how to apply for small business status. The process is relatively simple, but late completion of the steps will delay your submission or cost you $7,924.
Is there a small business discount for the Establishment Registration User Fee?
The above question is very popular, but unfortunately, the answer is no. Regardless of the size of your company or the number of products you distribute, there is only one fee for each establishment to be registered with the FDA. If you would like assistance with the registration and listing of your company, you can schedule an appointment with Medical Device Academy to help you with this. If you want to do it yourself, we have a posting that can help. We also offer US Agent services for companies that are located outside the USA.
Additional Resources for 510k submissions
If you would like additional training on 510k submissions or you would like to access Medical Device Academy’s templates, you can purchase all of our templates and 510k webinars on our 510k course webpage.
About Your Instructor for Small Business Qualification Fee Webinar
Rob Packard is a regulatory consultant with ~25 years of experience in the medical device, pharmaceutical, and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Rob was a senior manager at several medical device companies—including the President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certifications. From 2009 to 2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Rob’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications, and 510(k) submissions. The most favorite part of his job is training others. He can be reached via phone at 802.281.4381 or by email. You can also follow him on Google+, LinkedIn, or Twitter.