Qualifying as a small business with the FDA gives a company a substantial discount in the user fees required under the Medical Device User Fee Amendments (MDUFA). Businesses can qualify if they can prove their gross receipts are less than $100 million in the most recent tax year. Business leaders wondering how to apply have some new materials to help them through the process. CDRH Learn published a new module in October on how to complete an application to qualify as a small business under MDUFA. The module consists of a presentation that walks the learner stepwise through completion and submission of the form. There is also a transcript if you don’t wish to step through the presentation slides, Learners may also want to assemble the materials they will need to complete the application while following the presentation, and should refer to the list available the Small Business Determination Program website. While the filing period for small business qualification in FY2019 has passed (see my previous post here), it’s never to soon to start planning for next year.

Text Copyright © 2018 Katrina Rogers