Small Business Qualification Fee for 510k Submission (Webinar)

In this webinar you will learn the process of applying for small business qualification and payment of the MDUFMA fee for a 510k submission.

Application Form for Small Business Qualification

Small business qualification 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. At this beginning of August the FDA released the new MDUFMA fees for FY 2017–which begins October 1, 2016. Any companies that have not already filed an application for FY 2016 will now be applying for FY 2017 small business status instead. This portion of the webinar will explain what information is needed to complete the form and the requirements to be approved for small business status. Attendees 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 their User Fee Account to create FDA Form 3601 in order to include 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 this webinar?

This webinar was recorded on Wednesday, September 14, 2016. Anyone purchasing this webinar will receive a recording of the webinar and a copy of the native slide deck for $29.  There are 21 slides in the presentation. The presentation is 18 minutes in duration. All deliveries of content will be sent via AWeber emails to confirmed subscribers.


Please submit questions to me by email at regarding the Small Business Qualification Fee Webinar or call me at +1.802.281.4381.

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Small Business Qualification Fee Webinar available for $29.00.

Small Business Qualification Fee 150x147 Small Business Qualification Fee for 510k Submission (Webinar)
Small Business Qualification Fee for 510k Submissions

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 $2,000+. This live webinar will be 18 minutes in length. You will receive access to the recording and the native slide deck.

Price: $29.00

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About Your Instructor

Rob 150x150 Small Business Qualification Fee for 510k Submission (Webinar)

Rob Packard is a regulatory consultant with ~25 years 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 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 certification. From 2009-2012, 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 802.281.4381 or email. You can also follow him on Google+, LinkedIn or Twitter.


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