AdvaMed is calling for changes to the FDA’s draft guidance on the preliminary request for designation (Pre-RFD) program for combination products.
The guidance lays out the content and format sponsors will be expected to follow. The Pre-RFD process has fewer requirements than the full RFD program, and can be helpful if a product is very early in its development, or if the product’s classification — or the agency center it would be assigned to — is unclear or in dispute.
For AdvaMed, the guidance’s 15-page limit for Pre-RFD submissions is “insufficient” for sponsors to provide enough detail to obtain a definitive designation and requests modification “to allow for a more robust background documentation package.”
AdvaMed also noted concerns that analysis for a product’s primary mode of action (PMOA) is denoted as optional for the Pre-RFD process. The group points out that the official designation of the product is dependent on the PMOA. “The decision to optionally omit the PMOA analysis would seem to be counterproductive to industry members who are working towards an official designation,” AdvaMed says.