Aug 7, 2020

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.

Further details on how the program will operate and how interested parties can apply to participate are discussed in the document. Up to nine participants are needed for the pilot program, which is slated to begin on August 26, 2020. Applications for participation should be submitted to the FDA by August 19.​​

Related information from Emergo by UL on the US FDA and combination products:

  • FDA submission consulting for medical devices and IVDs
  • HFE user research support for medical devices, IVDs, and combination products
  • Whitepaper: Common use errors and design considerations for combination products
  • Webinar: Human factors engineering for medical devices
  • Webinar: Latest FDA expectations for human factors validation testing of combination products

Author

  • Timothy Herr

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