FDA Explains the Pre-RFD Process for Combination Product Designation
​​[Posted on: Thursday, February 22, 2018]

Sponsors looking to get semi-formal advice from FDA regarding which laws apply to their product; drug, device or biologic, got some help from FDA last week with the release of a new guidance about the pre-request for designation (pre-RFD) process. The RFD process that has been in existence for 15 years is run by the Office of Combination Products (OCP) at the FDA. The RFD process is a critical step to finding out what regulatory pathways apply to your product which in turn could drastically affect the feasibility of your product in the US. This is particularly important for products that are regulated differently in other countries. The most common issue is where a product is regulated as a device in Europe or Canada and would be classified as a drug by FDA. For combination products, determining which division would take the lead in reviewing your product will significantly affect the type of data and applications needed for the market approval of your product. And there are disputes when OCP’s decision is not acceptable or agreeable to the manufacturer. Traditionally, the decision of OCP about a product classification is considered final and almost impossible to change leading to sponsor’s dissatisfaction with the RFD review process. To address that, OCP launched the pre-RFD process in August 2016. Last week, OCP released its detailed guidance document describing the various aspects of the pre-RFD process. The key advantage of the pre-RFD process is that it is a semi-formal non-binding opinion from OCP based on the abbreviated information provided by the applicant. Once the applicant receives feedback from the OCP staff, it has three options: (1) apply the feedback and prepare for the regulatory pathway suggested by OCP, (2) prepare a formal RFD trying to address the issues raised by OCP regarding the reasons for its designation suggestion in an attempt to change the OCP’s formal decision, (3) Meet with the OCP staff to clarify and discuss the product in an attempt to change the decision before filing a formal RFD. Either way, the applicant gets a few chances to reverse a decision that was not possible earlier. The pre-RFD is a compromise and not a solution. Rarely does OCP change its decision and it would be hard to imagine that to change with the pre-RFD unless there is significant new information or new presentation of the information not included in the pre-RFD. But it does give the applicant opportunity to air its grievances with the FDA and give additional time to come to adjust with the regulatory realities for their product with the FDA.