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FDA Introduces the Pre-RFD Process

Making continuous improvements in the combination products program

Published: Thursday, August 25, 2016 - 15:43

One question that product sponsors often ask the U.S. Food and Drug Administration (FDA) is whether their medical product will be regulated as a drug, a device, a biologic, or as a combination product—and in the case of the latter, which FDA component will regulate it.

One way sponsors may determine how their product will be classified is to submit a Request for Designation (RFD) to the Office of Combination Products (OCP). This request requires the FDA to provide a written determination of product classification and/or which agency component will regulate the product if it’s a combination product. Sponsors have also been able to obtain less formal feedback regarding product classification through communications with the OCP.

We’re pleased to announce that the agency is making some changes to our internal procedures for responding to communications from sponsors regarding preliminary product classification assessments from the OCP. The Pre-Request for Designation (Pre-RFD) process is the result of cooperative efforts by the OCP, the Office of Medical Products and Tobacco, and CDER Lean, including a formal internal evaluation that incorporates current-state process mapping and identifies and integrates process improvements.

The Pre-RFD process shares some similarities with the RFD process. In both cases, the FDA’s assessment depends on sponsors providing a complete, clear, and detailed product description, which includes the product’s indication for use, its composition an/or ingredients, and an explanation of how it works. In most instances, both processes also require input from the product jurisdiction officers in the relevant centers and, if necessary, legal perspectives from the Office of Chief Counsel.

Once the OCP has received the necessary input, the office makes its assessment of the classification or center assignment for the product. OCP’s goal for Pre-RFDs is to respond to sponsors within 60 days following receipt of all information needed to initiate the review—the same timeline for responding to RFDs. During this review period, the office will communicate with the sponsors as needed.

When would the Pre-RFD process be useful?

The Pre-RFD process can be used at any point during medical product development. It may be preferable to the more formal RFD process when a sponsor would like to engage the FDA using a more interactive approach—a course that might be especially helpful when a medical product is at an early stage in its development, or when a sponsor is contemplating whether to develop a specific product, or what configuration of that product to pursue. In such cases, 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 promote better decision making and development of products for the sponsors.

The FDA’s Pre-RFD process flow. Click here for larger image.

Because the FDA’s feedback will be based on the information submitted, sponsors should bear in mind that the speed and quality of any review, whether Pre-RFD or formal RFD, is dependent on the quality of the submitted data.

The agency is developing a draft guidance about the Pre-RFD process, which provides details about information sponsors should include in a Pre-RFD and describes the procedure for the FDA’s review. In addition, the agency plans to publish a list of product classifications for various types of products. We believe this list will offer additional transparency and clarity to sponsorsthat will in turn foster innovation and promote better health for patients. We welcome your feedback regarding the Pre-RFD and RFD programs, as well any other thoughts regarding the jurisdictional assessment of products.

A sponsor that wishes to submit a Pre-RFD or an RFD for a product can find detailed information at the OCP website, or contact the OCP for further assistance.


About The Authors

Thinh Nguyen’s picture

Thinh Nguyen

Thinh Nguyen is the FDA’s Director of the Office of Combination Products.

Rachel E. Sherman’s picture

Rachel E. Sherman

Rachel Sherman, M.D., M.P.H., is FDA’s Associate Deputy Commissioner for Medical Products and Tobacco.