The FDA’s Office of Combination Products (OCP) has issued final guidance titled “How to Prepare a Pre-Request for Designation (Pre-RFD).”
This guidance is designed to assist manufacturers in obtaining preliminary, non-binding feedback from the FDA regarding a product’s regulatory identity (drug, device, biologic, or combination product) and the appropriate Agency Center (CDER, CDRH, or CBER) responsible for review.
Key Highlights:
- What is a Pre-RFD? A submission to OCP asking for an informal, non-binding feedback regarding the regulatory identity or classification of a human medical
- When to submit it? When the classification of a product and/or the Agency center to which it should be assigned is unclear or in dispute.
- What information to include? Guidance lists essential elements like product description, intended use/indications, how it works (mode of action) etc.
- Timeline & review process: OCP aims to confirm within about 10 business days whether the submission is complete for review; full feedback generally within approx 60 calendar days for complete submissions.
Why this matters for regulated product developers:
- Clarifies the regulatory context you’re on and which FDA center you’ll be interacting with — enabling strategic planning early.
- Helps avoid mis-filing, rework, or submitting under the wrong classification which could delay your product.
- Useful especially for complex or combination products, where the identity and mode of action may cross drug/device/biologic boundaries.
How Instituto Pedro Nunes can support your organisation:
- Gap analysis: review your product concept and development plan against the Pre-RFD criteria.
- Drafting support: help prepare a clear, concise Pre-RFD submission adhering to FDA expectations.
- Strategic advice: aligning your development plan, regulatory pathway and submission timing based on feedback.
- Interaction guidance: support interactions with the OCP including responses, meeting preparation, and next-steps after feedback.
More info, here.