FDA Explains How To Prepare Pre-Request For Designation Submissions

By Jof Enriquez,
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The U.S. Food and Drug Administration (FDA) has released a draft guidance detailing how device sponsors should prepare and submit Pre-Request For Designation (Pre-RFD) submissions to seek early input from the agency during a combination product's early stage of development, when the sponsor is contemplating a specific configuration of the product.

Besides submitting, via an existing formal mechanism, a Request for Designation (RFD) request to the Office of Combination Products (OCP), sponsors can now opt for a less formal method of seeking feedback through the new pre-RFD process formalized by FDA in August. The Pre-RFDs are considered less stringent because sponsors are not required to provide a recommendation for classification and assignment of their product along with corresponding studies, and are not required to discuss the classification of currently marketed products that they believe to be similar to their product.

According to RAPS, the new Pre-RFD process allows sponsors to ask FDA how their product will be classified (drug, device, biological, or combination product), and which of the agency's three review centers will be responsible for reviewing and regulating the product if it is considered a combination product, before submitting a marketing application to FDA.

Whereas submitting an RFD results in sponsors receiving a formal, binding, written determination for the sponsor’s product with respect to classification and/or center assignment, the more flexible Pre-RFDs will yield preliminary jurisdictional assessments, which are non-binding, and "have become increasingly customary with sponsors, and for some, even preferable to the formal RFD process," said FDA.

Even though Pre-RFDs can be submitted at any point during medical product development, FDA says it is "especially beneficial when the classification of a product or the Agency Center to which it should be assigned is unclear or in dispute and your product is very early in its development, or if you are contemplating whether or not to pursue a specific configuration or a specific indication."

Sponsors can request a meeting either prior to or after submission of a Pre-RFD, but FDA warns that meetings held after submitting a Pre-RFD (but before FDA provides feedback) may extend the overall review timeframe for the product/s.

Within 5 business days of receiving a Pre-RFD, OCP aims to review the submission to ensure that it has adequate information to make a preliminary assessment. OCP will acknowledge the sponsor via email if a review will proceed, or will ask for additional information before proceeding with the review. Granted complete information provided by the sponsor, FDA says it intends to provide feedback within 60 calendar days of receipt, during which time FDA is open to receiving questions and clarifications from the sponsor. The agency says it will notify sponsors ahead of time if it takes longer to review a combination product.

If sponsors change a product's indication or ingredients, they should contact FDA promptly, as a new Pre-RFD request will be required.

"Additionally, if you have classification or assignment questions regarding multiple related products or product families that have different configurations, ingredients, and/or proposed uses or indications, we recommend submitting a separate Pre-RFD for each product," FDA states in the draft guidance.

For disputed decisions, sponsors can make requests for reconsideration within 15 calendar days of receipt of the designation letter, and FDA says it intends to review and act upon requests for reconsideration within 15 calendar days of receipt.

The 14-page guidance document details the recommended format and specific content of a Pre-RFD submission. FDA enjoins sponsors to devote particular attention to the following information on Pre-RFD submissions:

• A complete description of the product, including its composition (what is your product?);
• The intended use/indications for use of the product (why would your product be used?);
• The methods of action of the product (how does your product work?);
• If your product may be a combination product, information you may have, if any, regarding the relative contribution of each of its components to the overall intended therapeutic/diagnostic effects of the combination product; and
• Any claims you have made or plan to make about your product.