BIO, AdvaMed Seek to Tweak FDA’s New Pre-Request Draft Guidance for Combo Products

Regulatory News

Industry groups BIO and AdvaMed are seeking some changes to the US Food and Drug Administration’s (FDA) guidance on requesting informal input on combination product designations.

Background

Under what’s known as the pre-request for designation (pre-RFD) program, sponsors can 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.

According to draft guidance issued in January, FDA lays out the content and format it expects sponsors to follow when submitting pre-RFDs, noting they are "especially beneficial when the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."

Comments

Under its “general comments,” AdvaMed questions the size of the document package that can be submitted to FDA, noting that “current consensus is that the 15 page limit is often insufficient to provide enough detail to obtain a definitive designation from the Request for Designation process.”

The group representing device companies also said it has “concerns that the primary mode of action (PMOA) is denoted as optional for the Pre-RFD process when the official designation of the product is dependent on the PMOA.”

The group is also pushing FDA to make a determination on the intended use/indications for use rather than the intended claims of a product.

BIO, meanwhile, requests that FDA add metrics in its reports to Congress (that should be made available online in a more real-time basis) to capture response times and the number of extensions.

The group representing biotech interests also seeks clarification on how sponsors may engage with FDA through informal dialogue in this process similar to what is allowed in the current RFD process.

Comments