Pre-RFD Process: FDA Introduces New Process to Classify Combination Products

During product development some sponsors struggle to determine how their product will be regulated by the FDA.  Will it be considered a drug, medical device, biologic, or combination product?  Based on the product’s primary mode of action, the FDA makes determines how the product will be classified and which offices will carry out the premarket review.  This determination can have a significant impact on a product’s development; as such, FDA allows sponsors to request a designation early by submitting a Request for Designation (RFD).

On August 11^th, the FDA announced that it will be making some changes to its “internal procedures for responding to communications from sponsors regarding preliminary product classification assessments from OCP.”  Among these “changes” described by the FDA is the introduction of the Pre-Request for Designation (Pre-RFD) process, which will allow sponsors to seek a product classification from FDA, but requires less information than a formal RFD submission.

Pre-RFD Submissions

According to FDA’s blog post, the Pre-RFD process can be used at any point during product development.  For sponsors looking to use a more interactive approach to engage the Agency, the Pre-RFD process may be preferable to the more formal RFD process.  FDA states that sponsors may find the Pre-RFD process beneficial for the following reasons:

1. “Sponsors are not required to provide a recommendation for classification and assignment of their product along with a corresponding rationale (e.g., bench studies; clinical studies) for that recommendation.”
2. “Sponsors are not required to discuss the classification of currently marketed products that they believe to be similar to their product.”
3. “Sponsors can receive preliminary feedback and information from the Agency that is derived from a structured and efficient process. The feedback will ultimately help lead to better decision-making and development of products for the sponsors.”

Similarities with RFD Submissions

While there are a number of benefits to the Pre-RFD process, there are also many similarities between the RFD and Pre-RFD processes.  These include:

• For both submissions, FDA’s assessment is dependent on the sponsor providing a product description that is complete, clear, and detailed. This should include the product’s indication for use, composition/ingredients, and an explanation of how it works.
• Both processes “require input from the product jurisdiction officers in the relevant Centers and, if necessary, legal perspectives from the Office of Chief Counsel.”
• For both Pre-RFD and RFD submissions, OCP’s goal is to respond to sponsors within 60 days of receiving all of the information necessary to initiate the review.

FDA notes that its feedback is based on the information that is submitted, thus “sponsors should bear in mind that the speed and quality of any review, whether Pre-RFD or formal RFD, is highly dependent on the quality of the submitted data.”

In addition, FDA also states that it is in the process of developing a draft guidance on the Pre-RFD process, and that it plans to publish a list of product classifications for various types of products.  The Agency welcomes any and all feedback concerning the RFD and Pre-RFD processes, and encourages individuals to voice any questions, comments, or concerns that they may have.

Are you in the process of developing a combination product? We can help you obtain a designation for your product and achieve a successful interaction with FDA.  To learn more about our services and how we can help you, contact us today.