U.S. flag An official website of the United States government
  1. Home
  2. For Industry
  3. FDA User Fee Programs
  4. Medical Device User Fee Amendments (MDUFA)
  5. MDUFA Guidance Documents
  1. Medical Device User Fee Amendments (MDUFA)

MDUFA Guidance Documents

The guidance documents listed below describe FDA’s Medical Device User Fee Program. Additional guidance documents developed under MDUFA agreements can be found in FDA’s Guidance Document Search.

User Fee Guidance Documents

Back to Top