The FDA has revised its previous guidance of the same name, which was issued on August 1, 2018. The FDA notes that “[a] draft select update to this document was issued on February 22, 2024.” The revised final guidance (Medical Device User Fee Small Business Qualification and Determination) “includes updates that describe how FDA will determine if a small business is experiencing ‘financial hardship,’ which would make the business eligible for a waiver of their registration fee (“Small Business Registration Fee Waiver”). The guidance details the types of information an entity seeking the waiver may submit for FDA’s consideration in determining whether to grant the Small Business Registration Fee Waiver, including entities that are in jurisdictions without a national taxing authority. The guidance is also being updated to reflect the planned replacement of Forms 3602 and 3602A with a single combined form (Form 3602N).”
The document provides an overview of the program including eligibilities, information for both U.S. and foreign entities including advice on how to prepare a national taxing authority certification, and information that must be included in any request for small business qualification.
It discusses small business fees and waivers as well as the benefits of qualifying as a small business, and it has a frequently asked questions section. The rules are fairly straightforward, but to meet the financial requirements, it must be noted that the firm applying must include data inclusive of its affiliates. Please review the document carefully to understand whether your firm meets the requirements outlined for eligibility for fee reductions or waivers when applying.
