Dispute Resolution Process for Combination Product Review Timelines
This guidance outlines the process for submitting and resolving formal disputes regarding the timeliness of premarket review of combination products. It specifically addresses how applicants can present disputes when FDA does not review and act on premarket submissions within applicable timeframes.
Recommended Actions
- Document all timeline commitments and deadlines for the combination product review
- Monitor review timelines against applicable PDUFA/MDUFMA performance goals
- If timelines are not met:
- First attempt resolution with reviewing division and office
- Contact Center Ombudsman if needed
- Submit formal dispute to OCP as last resort with all required information
- When submitting to OCP:
- Provide complete documentation package
- Be prepared for follow-up discussions
- Monitor any new target dates established
- Maintain communication records with FDA throughout the dispute resolution process
- Contact OCP for follow-up if new target dates are not met
Key Considerations
Other considerations
- Timeliness disputes should be presented after the relevant deadline has been missed but before review completion
- For combination products reviewed under two applications, timeframes for each application type apply separately
- Dispute resolution requests should first be attempted with the lead division before contacting OCP
- Required information in dispute resolution requests:
- Contact information
- Product name and combination product justification
- Request for Designation number (if applicable)
- FDA Center and reviewing division information
- Application number and type
- Relevant user fee performance goal
- Due date for action
- FDA contact person
- Summary of division’s response regarding timeliness
- Summary of issues affecting review timeliness
Relevant Guidances
- Premarket Review Pathways for Combination Products
- 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
- User Fees for Combination Products and Associated Waivers
- Compliance Policy for Combination Product Postmarketing Safety Reporting Requirements
Related references and norms
- 21 CFR 3.2(e): Definition of combination products
- 21 CFR Part 312: Investigational New Drug Applications
- 21 CFR Part 812: Investigational Device Exemptions
- 21 CFR Part 814, Subpart H: Humanitarian Use Devices
Original guidance
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