FDA Pre-RFD Guidance 2025 – How to Prepare a Pre-Request for Designation

The FDA Pre-RFD Guidance 2025 provides updated instructions for sponsors of combination products seeking preliminary feedback from the Agency. Replacing the 2018 guidance, it clarifies the Pre-Request for Designation (Pre-RFD) process, helping sponsors understand regulatory assignment, product classification, and interaction with responsible FDA centers (CDER, CBER, or CDRH). Early engagement can streamline combination product development and regulatory planning.

What the FDA Pre-RFD Guidance Covers

The November 2025 guidance is designed to support sponsors requesting informal, non-binding feedback on regulatory identity and classification of human medical products:

• Clarifies whether a product is regulated as a drug, device, biological product, or combination product.

• Identifies the responsible FDA center and office for regulatory review.

• Provides step-by-step instructions on requesting a Pre-RFD meeting, including required meeting materials, request format, and expected timelines.

• Supports early regulatory interactions, enabling sponsors to clarify responsibilities before formal submissions.

Key Changes from the 2018 Guidance

The 2025 guidance introduces several important updates:

• Updated meeting interaction instructions: Provides detailed timelines for Pre-RFD meetings, including submission review and Agency response expectations.

• Improved clarity on meeting materials: Specifies what information sponsors must include to facilitate meaningful feedback.

• Alignment with modern combination product practices: Reflects current FDA processes and organizational responsibilities, particularly across CDER, CBER, and CDRH.

• Non-binding preliminary feedback: Emphasizes that Pre-RFD responses do not represent final regulatory decisions but help sponsors plan development strategies.

Benefits for Combination Product Sponsors

Engaging in the Pre-RFD process allows sponsors to:

• Confirm regulatory assignment and identify the responsible FDA center.

• Reduce uncertainty around classification before formal submissions.

• Improve efficiency and planning for Investigational New Drug (IND), Investigational Device Exemption (IDE), or marketing applications.

• Address potential issues early, minimizing downstream delays.

How to Prepare a Pre-RFD Submission

Sponsors should follow these practical steps:

1. Determine product scope: Clearly define your product’s intended use and constituent parts.

2. Assemble meeting materials: Include product description, development plan, and regulatory questions.

3. Submit Pre-RFD request: Use FDA’s recommended format and channels for submission.

4. Prepare for meeting: Review potential discussion topics and Agency questions in advance.

5. Follow timelines: FDA guidance outlines expected response times and meeting scheduling.

Internal links

• Learn more about FDA US Medical Device Registration

External links

• FDA Pre-RFD Guidance 2025

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