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.
What You Need to Know? 👇
What is a premarket review timeliness dispute for combination products?
A timeliness dispute arises when FDA doesn’t review and act on a combination product’s premarket submission within the applicable time frame, and the applicant presents the issue to the Office of Combination Products (OCP) for resolution.
When should I submit a timeliness dispute resolution request to OCP?
Submit the request after the relevant deadline has been missed but before the reviewing Center completes its premarket review. If FDA notifies you in advance that a deadline won’t be met, you can submit earlier.
What time frames apply to combination product reviews?
OCP uses PDUFA and MDUFMA performance goals as measures. For single applications, the relevant application type’s time frame applies. For dual applications, each application type’s respective time frame is considered separately.
What information must be included in a timeliness dispute request?
Include contact information, product name and combination rationale, Request for Designation number, reviewing Center/division, application number and type, relevant performance goals, due date, FDA contact, and summaries of FDA communications and your perspective on barriers.
Should I contact the reviewing division before submitting a dispute to OCP?
Yes, FDA recommends first trying to resolve disputes with the lead division, office, and center. Contact the appropriate Center ombudsman if needed before escalating to OCP for formal dispute resolution.
How does OCP respond to timeliness dispute resolution requests?
OCP contacts the reviewing division Director and Center Ombudsman to assess the situation, determine review status, identify completion barriers, and develop a completion plan. They provide feedback to applicants within 10 working days.
What You Need to Do 👇
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