On February 14, 2018, FDA issued nonbinding final guidance on How to Prepare a Pre-Request for Designation (Pre-RFD). FDA intends the guidance to explain the Pre-RFD process at the Office of Combination Products (OCP). The guidance also provides the recommended format and content for a Pre-RFD submission.

The final guidance contained minor edits and clarifications over the draft guidance from January 2017, a summary of which can be found on Finnegan’s IP FDA Blog. A Pre-RFD submission requests FDA’s preliminary, nonbinding assessment of “the regulatory identity or classification of a human medical product as a drug, device, biological product, or combination product.” The OCP’s assessment also provides information about the product’s assignment to the appropriate Agency Center—or for a combination product, which Agency Center will have primary jurisdiction—for premarket review and regulation. Therefore, submitting a Pre-RFD is unnecessary for products with a clearly established classification and jurisdictional assignment, but recommended for products where the assignment is unclear or in dispute. Though nonbinding, the feedback on a Pre-RFD represents the OCP’s best advice and rationale for the assessment, with consultation from the relevant Agency Centers.

FDA intends a Pre-RFD to be a succinct summary of the relevant information for the OCP to make a preliminary assessment, though there is no page limit. The submission should include a complete description of the product, how it works, the intended indications for use, and how the product will be marketed. For combination products, the submission should also include information on the relative contribution of the components. A Pre-RFD is considered less stringent than the formal Request for Designation (RFD) because it does not require an analysis of the product’s classification, primary mode of action, or comparison to related products, and does not require the submission of study results. It is also optional for the sponsor to make a recommendation regarding the appropriate Agency Center assignment.

The appendix to the guidance includes a Pre-RFD screening checklist of the information that should be in the submission. The OCP will use the checklist to perform an administrative review of the submission. For that reason, the guidance recommends formatting the submission with a separate heading for each item in the screening checklist. Within five business days of receipt, the OCP will send an acknowledgment that the assessment will proceed, or detailing the additional information needed. The OCP will then review and provide written feedback within 60 calendar days for most submissions.

The guidance also includes information on the procedure for arranging a meeting with the OCP to discuss a Pre-RFD, and what to do if the sponsor disagrees with the OCP’s preliminary assessment. Readers are encouraged to read the final guidance, also available on FDA’s website.