Last week the FDA posted their draft guidance for updates to the Medical Device User Fee Small Business Qualification and Certification. The update contains proposals for how financially struggling small businesses can qualify for a one-time fee waiver.

After a rocky economic year in 2023, many small businesses are looking for opportunities to cut costs and save money. Usually regulatory requirements are an area of fiscal no compromise. However, thanks to the Food and Drug Omnibus Reform Act of 2022, small business owners may get a reprieve from the typical registration fee for medical device establishments.

The draft guidance outlines the framework for how a small business can demonstrate financial hardship that allows them to waive the registration fee. To qualify for the waiver the business must:

• Have made less than $1,000,000 in sales on their most recent tax return,
• Previously registered with FDA and paid associated registration fees,
• Currently have filed for bankruptcy in the USA

If granted, the waiver can be used one-time only. Companies based outside of the US may also qualify if they meet similar requirements.

The draft guidance can be viewed here. The FDA is accepting comments on the guidance until Apr 22, 2024.

If you need help registering your small business with the FDA, reach out to us at quality@cannonqg.com.
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