Medical Device User Fee Small Business Qualification and Determination

Medical Device User Fee Small Business Qualification and Determination is sponsored by Food and Drug Administration (FDA). This program allows qualifying small businesses to receive reduced or waived user fees when submitting medical device applications, helping to lower the financial barrier for small businesses seeking FDA approval for medical devices.

Medical Device User Fee Small Business Qualification and Determination | FDA Skip to in this section menu Medical Device User Fee Small Business Qualification and Determination Center for Devices and Radiological Health Center for Biologics Evaluation and Research This final guidance updates the previous version of the guidance, titled “Medical Device User Fee Small Business Qualification and Certification; Guidance for Industry, Food and Drug Administration Staff and Foreign Governments,” issued on August 1, 2018.

The guidance 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).

You can submit online or written comments on any guidance at any time (see 21 CFR 10. 115(g)(5)) If unable to submit comments online, please mail written comments to: Food and Drug Administration 5630 Fishers Lane, Rm 1061 All written comments should be identified with this document's docket number: FDA-2018-D-1873 .