When managing regulatory submissions, efficiency is key—especially when it involves changes to the sterilization process for multiple medical devices. The FDA allows bundling of such changes into a single submission under certain conditions, helping manufacturers save time and resources. In this blog post, we’ll guide you through the essentials of bundling sterilization process changes effectively.
What Is Bundling?
Bundling refers to combining multiple devices or indications into a single pre-market submission. This strategy reduces regulatory burdens by allowing related scientific and regulatory issues to be addressed cohesively. It also limits user fees to a single submission, provided the devices and changes meet specific FDA criteria.
When Is Bundling Appropriate?
To determine if bundling is suitable for your sterilization process changes, consider these key principles:
- Similarity of Devices:
- Devices must have similar designs, materials, or intended uses.
- The same sterilization process must apply across all devices in the bundle.
- Single Review Group:
- All devices must be reviewed by the same FDA division to ensure an efficient evaluation.
- Efficient Reviewability:
- Supporting data should address the sterilization process uniformly across all bundled devices.
Examples of Bundling in Sterilization Submissions
- PMA Example:
A manufacturer can bundle a sterilization facility change for multiple cardiac devices if all devices use the same facility, process, and validation data. - 510(k) Example:
Devices undergoing a transition from ethylene oxide (EtO) sterilization in a fixed chamber (Established Category A) to EtO in a flexible bag system (Established Category B) can be bundled, provided they are similar and reviewed by the same FDA division.
Steps to Bundle Sterilization Submissions
- Conduct Comprehensive Validation:
Prepare scientific evidence demonstrating that the new sterilization process is effective and safe for all devices in the bundle. - Consult FDA Guidance:
Refer to the FDA’s “Bundling Multiple Devices or Multiple Indications in a Single Submission” guidance for specific bundling principles and examples. - Document Changes Thoroughly:
Clearly outline the devices, sterilization changes, and shared supporting data in your submission. - Leverage Pre-Sub Meetings:
Engage the FDA early through a Pre-Submission (Pre-Sub) meeting to confirm your bundling approach and address any concerns.
Limitations of Bundling
While bundling can be an efficient approach, it has limitations:
- Devices with significantly different characteristics or requiring distinct supporting data may not qualify for bundling.
- Including too many unrelated minor changes can complicate the review process and undermine the benefits of bundling.
The Benefits of Bundling
When done correctly, bundling sterilization process changes offers several advantages:
- Cost Savings: A single user fee applies to the bundled submission.
- Streamlined Reviews: Unified documentation simplifies the FDA’s evaluation process.
- Faster Approvals: Reduced regulatory complexity leads to quicker market access.
Takeaway
Bundling sterilization changes into a single FDA submission is a strategic approach for manufacturers managing multiple devices. By adhering to FDA guidelines, preparing robust validation data, and engaging the agency early, you can reduce regulatory burdens and focus on delivering safe, effective medical devices to the market.
If you’re considering bundling your sterilization changes, start with a Pre-Submission meeting to discuss your strategy with the FDA and ensure a smooth submission process.
References: