Small Business Determination (SBD) Program

If your business qualifies as a Small Business under the FDA guidelines for the SBD program,
you could be eligible for reduced user fees for certain types of registrations/renewals with the Agency - this applies not only to U.S. based organizations but also to international companies who sell product in the U.S.

According to the FDA, "a small business is defined as a business, including its affiliates, whose gross receipts and sales are less than $100 million for the most recent tax year". The deadline to file as a Small Business and take advantage of the significant User Fee cost savings is October 1, 2020.

Just as an example, under the 2020 User Fee schedule a small business can save over $8,500 on a 510(k) submission alone when compared to the standard fee. There is no cost associated with the Small Business Certification Request, so you have nothing to lose! We know your time is precious and you probably have more concerning matters to attend to, so let us take care of the paperwork.

Register as a Small Business by October 1, 2020 to take advantage of these savings!

Who doesn't like saving money? Contact us today and an experienced consultant will help determine if you qualify as a small business, and do all the heavy lifting for you.

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