FDA updates Pre-RFD guidance with new recommendations

The US Food and Drug Administration (FDA) has released a new final guidance on preparing a pre-request for designation (Pre-RFD) with the Office of Combination Products (OCP), that contains information on best practices for engaging with OCP in the Pre-RFD process.

The Pre-RFD process is an informal process for sponsors to get feedback from OCP on whether a medical product will be regulated as a combination product or non-combination product, as well as which product center will be the primary center involved with the regulation and/or premarket review of the product.

The document updates a guidance finalized in February 2018 with the same title.

“This replacement is intended to enhance the transparency, consistency, and efficiency of the Pre-RFD program by clarifying the information to include in a Pre-RFD submission and providing clarifications and updates to the Pre-RFD process,” the agency wrote in its new final guidance.

Requesting a meeting

FDA said that a sponsor can contact OCP before requesting a meeting, noting that “many questions can be resolved promptly without a meeting.”

If a meeting is needed, it can be conducted in-person, via teleconference, or in a virtual face-to-face format. OCP conducts two types of meetings: an informational meeting prior to a Pre-RFD submission held within 6 weeks of receiving a complete meeting package, and an explanatory meeting following an assessment for a Pre-RFD held 2 weeks after receiving a meeting request.

OCP said it has found that virtual meetings are “just as effective in achieving meeting objectives and are logistically more efficient than face-to-face in person meetings.”

Details on Pre-RFD Information

OCP also provided more details in the new guidance on the type of information that should be included in a Pre-RFD.

In addition to a company’s contact info, a listing of all the components and ingredients, an explanation of how the product works, and a description of how the product will be marketed, sponsors should include a complete description of the product, such as its name, related submission number and submission type, the names and sources of components of the product and their applicable FDA regulatory submission numbers, and a photo or diagram of the product, according to FDA.

OCP said that information related to safety and effectiveness, or information related to the prevalence or impact of the disease or condition associated with the product should not be included in a Pre-RFD because “it typically does not help OCP understand how the product works.”

The agency emphasized that information provided in a Pre-RFD should be succinct and sufficient, and studies should be linked to public sources when available. Descriptions of studies that have not been published should include how the study was conducted, testing conditions, test articles and controls, and the results of the study and its conclusions. It added that sponsors should ensure that there are no contradictory statements in the Pre-RFD, it contains supported assertions, and provides explanations for assumptions.

Pre-RFD submission and feedback

The process for submitting a Pre-RFD remains largely the same in the new guidance: a sponsor can email OCP with the Pre-RFD in a Word document or PDF format with “Pre-RFD” in the subject line. However, an option to submit a Pre-RFD through standard mail has been removed in the new final guidance document.

OCP noted that information for most products can be described in a Pre-RFD that is 15-20 pages in length, not counting courtesy copies of published literature, though it can be longer depending on the product.

After a submission, OCP said it will aim to review Pre-RFDs and send an acknowledgment of receipt within 10 days, an increase from a target of 5 days from the previous final guidance document. FDA noted that some acknowledgments may take longer than 10 days, particularly if a submission contains a large amount of information. Feedback on a Pre-RFD will still be issued within 60 calendar days after OCP sends an acknowledgment of receipt.

If the sponsor disagrees with OCP’s assessment, they can now request an explanatory meeting, rather than contacting the office for a discussion of the findings. Sponsors also have the option to submit another Pre-RFD for the same product with additional information, which will be considered a new Pre-RFD and be subject to the 60-day review and feedback process.

OCP may send sponsors a request for additional information if the Pre-RFD does not have sufficient information to provide feedback to the sponsor about the product.

In response to requests for additional information, sponsors should include a document with OCP’s questions and the sponsor’s answers. The sponsors should also include a track changes version of the pre-RFD to highlight any changes made, as well as a clean version of the revised pre-RFD.

“We strongly encourage you to contact OCP before submitting your Pre-RFD if you have any questions, or if you are uncertain about the type of information to include,” OCP wrote.

Guidance

FDA updates Pre-RFD guidance with new recommendations

Related topics

Recommended content

Welcome to the new RAPS Digital Experience