The FDA actually reduced their fees this year, effective October 1, but the FDA offers fee reductions for small businesses too. Most of my clients qualify, but very few of these small businesses take advantage of the FDA fee reduction. 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 reduction or the companies have difficulty gathering the tax records required for the application.

On August 1, 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. The criterion for qualification is annual gross income of less than $100 million. This income threshold includes any subsidiaries in the US or abroad. If you have subsidiaries, you have to submit tax returns for each subsidiary. If you don’t subsidiaries, you only need to submit one of the following documents for your business:

Form 1040, Schedule C
Form 1040, Schedule C-EZ
Form 1065
Form 1065-B
Form 1120
Form 1120-F
Form 1120-S
Form 990 (for non-profits)

You only have to submit the most recent tax return. Therefore, your 2015 tax return should be your most recent tax return on October 1, 2016 (in 12 days). If you have a copy of your 2015 tax return, then you can fill out the application form and submit the tax return and the application form to the FDA for review and approval. This process takes 60 days, and many clients wait until they are just weeks away from a submission to apply.

Don’t wait!

If you think you might submit a 510(k) before October 1, 2016–submit your application on October 1. By December 1, 2016 you will receive your small business qualification identification number. This is all you need to take advantage of the fee reduction and save $2,345 on your next submission.

The form, and all the requirements for this application, are included in the free FDA guidance document:

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM514085.pdf

If you just don’t understand the guidance document, or you don’t have time to read all 36 pages, you can also purchase my webinar on the topic. It’s only $29 and it’s only 18 minutes long. In just 18 minutes you will know exactly what documents you need, what steps to follow, what forms to fill out and where to send your application. Every single question I have ever been asked about the process is answered in the 36 pages, but you could listen to my webinar on your cell phone while you drive your car home this evening–instead of reading the 36 pages. Just download it to your mobile device and play it.

http://medicaldeviceacademy.com/small-business-qualification-fee-webinar/

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