In 2022, a small business medical device manufacturer based in Jeffersonville, Indiana called the Office of Senator Braun to flag a shortcoming of legislation moving in Congress. Namely, as Congress considered statutorily required updates to the FDA user fee model, there was no consideration given to the size of filing fees on small businesses. As a result of this constituent’s outreach to identify the shortcoming, Senator Braun drafted legislation with Senator Maggie Hassan of New Hampshire, the Small Business Establishment Registration Waiver Act (S. 4385), to allow the FDA to waive annual establishment registration fees for small medical device manufacturers for which such fees present a financial hardship. Specifically, this bill provides authority for FDA to waive the registration fee for the smallest device manufactures, those with less than $1,000,000 in annual revenue, if the business can demonstrate to FDA that the registration fee represents a financial hardship to the business. It will allow companies to continue to manufacture devices that are doing good in the world with small profit. This bill was offered as an amendment during the Senate Committee consideration of S.4348, the Food and Drug Administration Safety and Landmark Advancements Act (FDASLA) of 2022 in June 2022, where it was adopted by the Committee on voice vote. President Biden subsequently signed this reform into law on December 29, 2022.