User Fees for Combination Products and Associated Waivers
This guidance provides information on application user fees for combination products, specifically addressing how FDA applies PDUFA (Prescription Drug User Fee Act) and MDUFA (Medical Device User Fee Amendments) fees. It covers scenarios where combination products are submitted as single applications or separate applications for constituent parts, and explains available fee waivers, reductions, exceptions, and exemptions.
Recommended Actions
- Determine if product qualifies as a combination product under 21 CFR 3.2(e)
- Evaluate whether single or separate applications are appropriate:
- Single application is generally preferred
- Consult with FDA if considering separate applications
- For single applications:
- Identify applicable fee program (PDUFA or MDUFA)
- Determine eligibility for waivers/reductions
- For separate applications:
- Document justification if FDA determination required
- Submit waiver requests 3-4 months before fees are due
- Include “Combination Product Waiver Request” designation
- Maintain communication with:
- Office of Combination Products for general guidance
- Division of User Fee Management for PDUFA matters
- CDRH Division of Industry and Consumer Education for MDUFA matters
- Submit any fee refund requests within 180 calendar days of fee due date
Key Considerations
Other considerations
- Single application submissions are subject to the applicable user fee associated with that particular type of application (PDUFA or MDUFA)
- When two applications are submitted by applicant choice, each application fee is assessed independently
- For FDA-determined separate applications:
- Public Health Waiver may apply if product protects public health and applicant has limited resources
- Barrier to Innovation Waiver may apply if product is innovative
- Total fees are generally reduced to equivalent of one application fee
- Innovation criteria include:
- Premarket Review Pathways for Combination Products
- Compliance Policy for Combination Product Postmarketing Safety Reporting Requirements
- Current Good Manufacturing Practice Requirements for Combination Products
- Postmarketing Safety Reporting Requirements for Combination Products
- Obtaining FDA Feedback for Combination Products: Best Practices and Meeting Procedures
- Dispute Resolution Process for Combination Product Review Timelines
- Human Factors Studies and Related Analyses for Combination Products
Related references and norms
- 21 CFR 3.2(e): Definition of combination products
- 21 CFR 4.2: Definition of constituent parts
- 21 CFR 3.2(k): Definition of mode of action
- 21 CFR 3.2(m): Definition of primary mode of action
- 21 CFR 3.4: Assignment of combination products
Original guidance
- User Fees for Combination Products and Associated Waivers
- HTML / PDF
- Issue date: 2024-07-16
- Last changed date: 2024-07-16
- Status: FINAL
- Official FDA topics: Medical Devices, Pediatric Product Development, Drugs, Combination Products, Biologics, User Fees
- ReguVirta summary file ID: 0bf6a17f00d2e9ee0e9260da92a4f8f7
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