OMB control number
MDUFMA Small Business Qualification Certification
OMB 0910-0508 ยท HHS/FDA.
OMB 0910-0508
The Medical Device User Fee and Modernization Act of 2002 (MDUFMA) requires FDA to collect a user fee from each person who submits certain medical device applications for FDA review. A "small business" is eligible for reduced or waived fees. If an applicant does not provide information to FDA demonstrating to FDA's satisfaction that the applicant is a small business, the applicant must pay the standard (full) fee for any application it submits.
The latest form for MDUFMA Small Business Qualification Certification expires 2028-07-31 and is listed under ICR 202605-0910-003.
Latest Forms, Documents, and Supporting Material
| Document | Type |
|---|---|
 Form FDA 3602N MDUFA Small Business Determination Request | Form |
| Form FDA 3602N MDUFA Small Business Determination Request | Form |
 83-C 0910-0508 FDA 3602N.docx | Justification for No Material/Nonsubstantive Change |
| 83-C 0910-0508 FDA 3602N.docx | Justification for No Material/Nonsubstantive Change |
| 0508_Supporting Statement A_2025.docx | Supporting Statement A |
| 0508_Supporting Statement A_2025.docx | Supporting Statement A |
 MDUFMA Small Business Qualification Certification (Form FDA 3602 and Form FDA 3602A)) |
Form |
| MDUFMA Small Business Qualification Certification (Form FDA 3602 and Form FDA 3602A)) |
Form |
| MDUFMA Small Business Qualification Certification (Form FDA 3602 and Form FDA 3602A)) |
Other-Guidance: Medical Device User Fee Small Business Qualifica |