USA – US FDA launches pilot program for RFD and Pre-RFD electronic submissions process

The US FDA’s Office of Combination Products (OCP) announced a pilot program in the Federal Register to help the OCP evaluate a potential new electronic submissions process for Requests for Designation (RFD) and Pre-RFD. The RFD and Pre-RFD are ​routes for sponsors to gain OCP feedback on whether a medical product will be regulated as a drug, a device, a biological product, or a combination product. The major difference between the two is that the RFD route yields a binding determination, while Pre-RFD is informal and meant to constitute part of an ongoing conversation between the sponsor and the OCP.

Electronic submissions pilot program intends to boost efficiency and sponsor awareness of requirements

The pilot program is intended to help the OCP evaluate the functionality of the electronic submissions process, with the aim to enhance the efficiency and completeness of the RFD and Pre-RFD submissions. While the OCP currently accepts emailed submissions as well as paper copies, much of what they receive lacks necessary information to conduct a review, despite the existence of FDA guidance on RFD creation. The more structured format of the electronic submissions process being tested is meant to ensure that sponsors understand everything they are expected to provide and do not overlook any important pieces…