The FDA just issued final revised guidance explaining how sponsors can get preliminary, non-binding FDA feedback on a product’s regulatory identity (drug, device, biologic, or combination) and Center assignment (CDER, CDRH, or CBER).
It replaces the Feb 2018 version to improve transparency, consistency, and efficiency.
Here are the key points at a glance:
▪️ Use Pre-RFD when classification or Center is unclear or in dispute. It’s *not needed* for products with well-established pathways, and it’s not appropriate for vague concepts without defined composition and intended use/indication.
▪️ What you get: a written, preliminary, non-binding assessment with FDA’s rationale, coordinated with relevant Centers (and OCC as needed). If the product later changes materially, that feedback may no longer apply.
▪️ What to include (keep it concise but sufficient):
– Sponsor and single point of contact (name, email, phone).
– Product description: name; any related FDA submission numbers; components with names, sources, and regulatory/marketing history; photo/diagram.
– Intended use/indication (focus on one) and any claims; instructions/conditions of use.
– A complete component list (active/inactive), purpose of each, and specific amounts/concentrations (exact targets, not ranges).
– If biologically derived: source, processing/manufacture, and characterization.
– How it works (overall and by component), with data supporting the MoA(s); if seeking device classification, provide data showing it meets the statutory device definition. Do not include general safety/effectiveness testing or disease prevalence (they don’t aid classification).
– If a combo product is possible: info on the relative contributions/PMOA.
– Marketing configuration: single-entity, co-packaged, or separately marketed parts labeled for use together.
Write clearly, avoid contradictions, support assertions, and explain assumptions. Summarize any unpublished study methods/results.
▪️ Format and responses to info requests: mirror the guidance’s headings. If FDA asks for more info, reply with (1) Q&A, (2) tracked-changes Pre-RFD, and (3) a clean revised Pre-RFD. Use a standard readable font and paginate.
▪️ Recommended length: ~15–20 pages (excluding courtesy copies of published literature).
▪️ Timelines: FDA screens for adequacy in ~10 business days, then aims to give feedback within 60 calendar days of accepting your submission. Timing depends on clarity, brevity, and complexity.
▪️ If you disagree or plans change: request an explanatory meeting, submit a new Pre-RFD with added data, or pursue a formal RFD for a binding decision. You may withdraw any time before FDA issues its assessment (email OCP).
▪️ After feedback, use the indicated Center for subsequent interactions and include the Pre-RFD response in future communications.