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

• FY 2016 Medical Device User Fee Small Business Qualification and Certification - Guidance for Industry, Food and Drug Administration Staff and Foreign Governments
• User Fees and Refunds for Premarket Notification Submissions (510(k)s) - Guidance for Industry and Food and Drug Administration Staff
• User Fees and Refunds for Premarket Approval Applications and Device Biologics License Applications - Guidance for Industry and Food and Drug Administration Staff
• Administrative Procedures for CLIA Categorization - Guidance for Industry and Food and Drug Administration Staff
• Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions - Guidance for Industry and Food and Drug Administration Staff
• User Fees for 513(g) Requests for Information - Guidance for Industry and Food and Drug Administration Staff
• User Fees and Refunds for De Novo Classification Requests - Guidance for Industry and Food and Drug Administration Staff
• FDA and Industry Actions on De Novo Classification Requests: Effect on FDA Review Clock and Goals - Guidance for Industry and Food and Drug Administration Staff
• FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Goals - Guidance for Industry and Food and Drug Administration Staff
• FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Goals - Guidance for Industry and Food and Drug Administration Staff