FDA Issues Draft Guidance for Preparing a Pre-Request for Designation

On February 15, FDA’s Office of Combination Products (OCP) announced the draft guidance, “How to Prepare a Pre-Request for Designation (Pre-RFD).” Don’t let the name fool you though.  Unlike the similarly named Pre-Submission, a Pre-RFD does not need to precede a formal RFD.  A Pre-RFD is, in essence, an informal RFD through which a sponsor may receive a preliminary, non-binding jurisdictional assessment.  The practice of requesting informal, non-binding feedback from OCP prior to or in lieu of a formal RFD is not new and has been occurring for many years.  The guidance provides additional details regarding the process for doing so.

The draft guidance indicates that a Pre-RFD should include a product description, proposed indications for use, and a description of how the product achieves its intended use. A Pre-RFD can also, optionally, include other information, such as a description of the product’s manufacturing processes, data/studies supporting the primary mode of action, information regarding jurisdictional assignment (e.g., classification, primary mode of action, sponsor’s recommendation), and description of similar or related products.  There is no page limit for a Pre-RFD, a significant advantage over an RFD, which is capped at 15 pages.  This feature of the Pre-RFD process will be particularly useful for sponsors with substantial data supporting their primary mode of action.

Once prepared, the draft guidance indicates that a Pre-RFD can be submitted to OCP by email or in hard copy through mail. As with most submissions these days, the draft guidance includes a short screening checklist that OCP will use to perform an administrative review of a Pre-RFD within five business days of receipt.  Once accepted for substantive review, OCP aims to review and provide written feedback regarding a Pre-RFD in 60 days.

The draft guidance appears to envision an interactive review process, stating that sponsors may contact OCP with questions at any time during the review process. OCP anticipates that it can provide jurisdictional feedback based on the information provided in a Pre-RFD.  The draft guidance, however, indicates that a sponsor may request a meeting with OCP to provide a better understanding of how the product works.  A sponsor can request a meeting at any time and should include in its meeting request an explanation of the issues to be addressed and any supportive information.  OCP estimates that it will need approximately four weeks to prepare for such a meeting.  The guidance appears to contemplate that such a meeting would take place prior to OCP’s feedback on a Pre-RFD. It seems to us, though, that such a meeting could also be helpful after receiving  OCP’s feedback.

The draft guidance indicates that (similar to an RFD) if a product is changed after OCP’s review, the Pre-RFD feedback may no longer be applicable. Changes can include both physical changes to the product as labeling changes such as the indications for use.  If changes are made, the guidance recommends contacting OCP suggesting that a Pre-RFD could be an iterative process.  For example, if there are particular elements of a product that put it in one category or another, those could be changed and a new Pre-RFD submitted for the modified product in an effort to receive a different (potentially more favorable) jurisdictional assignment.

In sum, we think this draft guidance is informative and useful for sponsors that are interested in a more flexible, non-binding process for getting jurisdictional feedback from OCP, as compared to the traditional RFD process.