FDA Releases Updated Pre-RFD Guidance with Key Regulatory Recommendations
Overview of the Update
In November 2025, the Food and Drug Administration (FDA) made public a new version of its “How to Prepare a Pre-Request for Designation (Pre-RFD)” guidance, which explained in clear terms the manner in which the sponsors could receive preliminary feedback on medical products' classification and assignment. The update reflects the FDA’s aim to increase transparency, consistency, and efficiency of the Pre-RFD program - an informal but valuable step for sponsors uncertain about their regulatory pathway.
What’s New: Key Recommendations
Enhanced Clarity on Submission Content
The revised guidance emphasizes that sponsors should provide a clear description of the product, its indication, and how it works (mode of action), especially for products where classification (drug/device/biologic/combination) or Centre assignment (CDER, CDRH, CBER) is unclear.
Stronger Focus on Combination Products
Combination products, those involving elements of drug, device, and/or biologic, attract particular attention. The updated guidance reinforces that classification and primary mode of action (PMOA) remain central, even for Pre-RFD submissions. This is especially relevant for sponsors of advanced therapies, drug-delivery devices, and other hybrid technologies.
Defined Expectations for Timing and Format
While the Pre-RFD process remains voluntary and non-binding, the guidance sets an expectation that the Office of Combination Products (OCP) will acknowledge a submission’s receipt and aims to provide its assessment within approximately 60 calendar days after acceptance. Sponsors are encouraged to keep submissions concise (typically 15-20 pages) with a clear format.
Why the Update Matters for Sponsors
For organizations developing devices, biologics, or combination products, early regulatory clarity can reduce risk, streamline submission planning, and support efficient allocation of resources. The updated guidance clearly signals that the FDA expects better-structured submissions and is prepared to provide more predictable feedback. Whether you are planning a 510(k) submission, a Premarket Approval (PMA), or a novel hybrid product, using the Pre-RFD mechanism smartly can strengthen your regulatory strategy.
How Elexes Helps You Leverage the New Guidance
At Elexes, we specialise in regulatory strategy and submissions, including FDA pathways, CE Marking, ISO 13485 quality systems, and more. With the new Pre-RFD guidance in place, our team can help you evaluate whether submitting a Pre-RFD is advisable, compile the required documentation, and engage with the FDA’s OCP for you. If your product sits in the grey zone of classification or involves multiple jurisdictions, we can map a clear regulatory plan that aligns with both U.S. and global requirements.
Recommended Next Steps
⦿ Review the final guidance document on the FDA website.
⦿ Assess whether your product’s classification or Center assignment could benefit from a Pre-RFD submission.
⦿ Engage a regulatory partner (like Elexes) early to structure your submission and streamline the review process.
Ready to align your product strategy with the latest FDA Pre-RFD guidance? Contact Elexes today for expert support and let us guide you through every step of your regulatory journey.
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