After announcing a new program for sponsors to request earlier, informal input on combination product designations last August, the US Food and Drug Administration (FDA) has issued a new draft guidance detailing how to prepare such requests.
Specifically, this program, referred to as pre-request for designation (pre-RFD) program, allows sponsors to ask FDA how their product will be classified (drug, device, biological product 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.
Previously, sponsors are able to request a formal, binding, designation from FDA by submitting a request for designation to the Office of Combination Products (OCP).
Alternatively, sponsors could seek out an informal, non-binding, assessment from OCP, however, that process has not been formalized until now.
Over time, FDA says that many sponsors have come to prefer the flexibility afforded by the informal designations. "These informal methods of obtaining feedback have become increasingly customary with sponsors, and for some, even preferable to the formal RFD process," FDA writes.
As such, FDA says it has created the pre-RFD program in an effort to make the process for obtaining informal input on combination product designation more consistent and transparent.
In the draft guidance, FDA lays out the content and format it expects sponsors to follow when submitting pre-RFDs.
According to the draft guidance, pre-RFDs may be submitted to FDA at any point during product development, and are "especially beneficial when the classification of a product or the agency center to which it should be assigned is unclear or in dispute, or if you are contemplating whether or not to pursue a specific configuration or a specific indication."
While FDA says that it should be able to make its preliminary assessment in most cases "based on a well written pre-RFD," sponsors are able to request meetings with the agency either prior to, or after, submitting their pre-RFD.
If requesting a meeting, FDA cautions sponsors that the review time for their pre-RFD may be extended, and requests that their meeting request should be an explanation of what they hope to discuss.
After receiving a pre-RFD, FDA says it intends to review the submission to ensure it has the necessary information to complete its assessment within five business days, and either inform sponsors that the request was accepted or that additional information is needed.
Once complete information is provided, FDA says it plans to provide a written response with a preliminary product classification and center designation within 60 days, though it notes that in cases where it will not be able to meet the 60-day window, that it will contact the sponsor ahead of time.
FDA also cautions sponsors that if they change their product significantly during the pre-RFD process, the feedback given by OCP may no longer be applicable and a new pre-RFD process may need to be submitted.
Additionally, the agency also asks that sponsors submit separate pre-RFD requests for "multiple related products or product families that have different configurations, ingredients, and/or proposed uses or indications."