MDUFMA Small Business Qualification Certification

OMB 0910-0508

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 2022-05-31 and can be found here.


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