Combination Product Industry News & Guidance
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Navigating the Next Wave of FDA Shifts for Combination Products
What You Need to Know (and Why You Should Join Our Upcoming Webcast)
Combination product teams are entering a new era of regulatory clarity—and complexity.
The FDA is issuing multiple guidances that collectively redefine how combination product developers demonstrate safety, quality, and lifecycle control. For executives and technical leads, the challenge is no longer whether to integrate drug and device development—but how to operationalize that integration in real time.
At Suttons Creek, we’ve been helping sponsors anticipate these shifts long before they’re codified in guidance. In our upcoming free webcast, our experts will break down the four regulatory areas that are reshaping combination product strategy—and what you can do now to stay ahead of the curve.
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Managing EPRs and EDDOs: Preparing for the Post-Guidance Reality
When the FDA introduced the concept of Essential Performance Requirements (EPRs) and Expected Device Design Outputs (EDDOs), it redefined what “safe and effective” means for device-led combinations.
With draft guidance on the horizon, developers will soon face formal expectations for defining, testing, and validating these criteria—especially for electronically enabled injectors and other complex systems.
The risk: waiting for the final guidance before acting could lead to a “design-by-retest” spiral that consumes months of revalidation.
The opportunity: align EPRs and EDDOs with your risk management file now.
(More on the forthcoming guidance here.)
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Post-Approval Changes and Bridging Data: The Missing Lifecycle Playbook
Combination product lifecycle management is entering the spotlight. The FDA’s draft work on post-approval change guidance aims to clarify what constitutes a major, moderate, or minor change—and when bridging data can replace full clinical studies.
From new device suppliers to updated materials or labeling, these changes are inevitable. What’s changing now is the evidence standard for demonstrating continued safety and efficacy.
Key insight: forward-looking sponsors are designing bridging plans early—often as part of their initial development strategy—to minimize downstream disruptions.
(Read more background here.)
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Drug-Device CMC Integration: The Quality Story FDA Wants to See
FDA reviewers are no longer treating drug and device CMC sections as parallel tracks. The expectation is a single, integrated quality narrative—one that aligns stability, sterility, and manufacturing controls across both regimes.
This means your device QSR activities and drug GMP controls must intersect seamlessly, from supplier qualification to release testing.
The new Quality Management System Regulation (QMSR) and upcoming device-drug CMC clarifications will amplify this expectation, requiring proactive alignment between internal QA and regulatory teams.
What to do now: map your CMC documentation flow as one system, not two.
This not only mitigates RTF risk but also positions you for smoother global submissions.
(See related FDA updates here.)
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The UDI Draft Guidance: Unpacking Residual Questions for Combination Products
The June 2025 Unique Device Identifier (UDI) draft guidance represents one of the most consequential clarifications for cross-labeled, co-packaged, and drug-led combinations.
While the intent is simplification, it raises critical implementation questions—especially for products distributed through both drug and device channels.
Our perspective: early UDI strategy is more than labeling—it’s a cross-functional exercise in traceability, recall readiness, and data governance.
(Explore the draft guidance here.)
Join the Conversation
Each of these topics will be explored in detail during our upcoming Suttons Creek webcast, where our regulatory, quality, and CMC experts will discuss:
- What FDA reviewers are prioritizing in 2025 submissions
- How to organize cross-functional teams around new guidance expectations
- Practical examples of bridging, design output alignment, and CMC integration that shorten review times
Register now to secure access to the webcast recording and live Q&A
Don’t wait for the final guidance to be published before adapting your program. The next 12 months will reward companies that align early, integrate completely, and communicate clearly across the drug-device divide.
