About the Act
The Medical Device User Fee and Modernization Act of 2002 (MDUFMA),
P.L. 107-250, amends the Federal Food, Drug, and Cosmetic Act to
provide FDA important new responsibilities, resources, and challenges.
MDUFMA was signed into law October 26, 2002. MDUFMA has three particularly
significant provisions:
- User fees for premarket reviews.
- Establishment inspections may be conducted by accredited persons
(third-parties),
- New regulatory requirements for reprocessed single-use devices.
Action Dates
Federal Register
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Fees
Forms
MDUFMA Guidance Documents
MDUFMA Presentations
Frequently Asked Questions
Reports
- August 2004 GAO report discusses FDA's progress towards achieving
MDUFMA's performance goals [PDF]
Meetings
Related Resources
MDUFMA Webcasts
- Device User Fee Billing Procedures
View Webcast
(originally broadcast 4/9/03)
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Announcement of 2nd Annual
MDUFMA Stakeholder Meeting
Thursday, November 18, 2004
[More Information] |
New Related Resources
Pediatric Medical Devices
[Text]
New Reports
August 2004 GAO report discusses FDA's progress towards achieving
MDUFMA's performance goals
[PDF]
New Presentations
MDUFMA Quarterly Update (10/20/04)
[PowerPoint]
[Text]
Other Presentations
New Guidances
Implementation of the Inspection by Accredited Persons Program
[PDF] [Text]
Draft Guidance for Industry and FDA Staff: Application User
Fees for Combination Products [PDF]
[Text]
FY 2005 MDUFMA Small Business Qualification Worksheet and
Certification
[PDF] [Text]
User Fees and Refunds for Premarket Notification Submissions
(510(k)s)
[PDF]
[Text]
Other
MDUFMA Guidances
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Contact Us
Comment on MDUFMA
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