FDA issues draft guidance on new pre-request for designation process

The US Food and Drug Administration (FDA) has issued a new draft guidance on how to prepare a Pre-Request for Designation (Pre-RFD). The Pre-RFD process is means of obtaining informal, non-binding feedback on the classification of a human medical product as a drug, device, biological or combination product and understanding which of the agency’s review centers will be responsible for reviewing and regulating the product, should it be a combination product. Specifically, this guidance explains the Pre-RFD process at the Office of Combination Products (OCP) and helps a sponsor understand the type of information to provide in a Pre-RFD. In fact, the content and format of a Pre-RFD is described in some detail.

The guidance describes the process for review of Pre-RFDs, the timeframes for sponsors to receive feedback from the OCP and the procedure for the arrangement of meetings relating to a Pre-RFD. It is possible to have a meeting with OCP either prior to or after submission of a Pre-RFD. If you request a meeting after submission of a Pre-RFD but prior to feedback, this may lengthen the time of the review of your product. Within 5 working days of receiving a Pre-RFD, FDA will determine if the submission is complete or requires additional information. FDA’s goal is to provide written within 60 calendar days of receiving a complete Pre-RFD. However, more time may be required if the quality and adequacy of the information is poor or a large amount of data is submitted.

FDA also cautions sponsors that if they change their product significantly after submission of the pre-RFD process, for example, by changing the indication or ingredients, the feedback given by the OCP may become invalid. In such circumstances, FDA recommends contacting the OCP since a new pre-RFD may need to be submitted. Additionally, the agency asks that companies submit separate pre-RFDs for multiple related products or product families that have different configurations, ingredients, and/or proposed uses or indications.

If a sponsor disagree with OCP’s preliminary assessment, they can contact the OCP to discuss their findings. There are procedures to present additional information or new data that was not presented in the original Pre-RFD, although this will constitute a new submission. Ultimately, there are means by which the OCD’s decision can be challenged.

It should be noted that a Pre-RFD is not necessary for every product as some products have clearly established classification and jurisdictional assignments. The OCP has published a list of examples of these types of products on its website.

Click here to access the draft guidance.