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.
Document Name |
---|
Form |
Justification for No Material/Nonsubstantive Change |
Supporting Statement A |
No material or nonsubstantive change to a currently approved collection | 2024-08-14 | ||
Approved without change |
Extension without change of a currently approved collection | 2022-04-29 | |
Approved without change |
Extension without change of a currently approved collection | 2019-04-29 | |
Approved without change |
No material or nonsubstantive change to a currently approved collection | 2016-08-31 | |
Approved with change |
Extension without change of a currently approved collection | 2016-03-07 | |
Approved with change |
Extension without change of a currently approved collection | 2013-01-31 | |
Approved without change |
Extension without change of a currently approved collection | 2010-01-27 | |
Approved without change |
Extension without change of a currently approved collection | 2006-12-13 | |
Approved without change |
Extension without change of a currently approved collection | 2003-10-27 | |
Approved without change |
New collection (Request for a new OMB Control Number) | 2003-03-26 |