1/15/2020
The U.S. Food and Drug Administration (FDA) released a draft guidance “Requesting FDA Feedback on Combination Products” for comment. Combination products are made of a combination of two or more components that are drug, biologic, and/or device. They can be 1) components of one entity, 2) packaged together (such as a kit), or 3) packaged separately but intended to be used together. The purpose of the draft guidance is to clarify how the combination product sponsor can request feedback on regulatory questions and to describe best practices for communication with the FDA.
Combination products are unique due to their composition of different product types. It is relatively easy to know that a medical device product is assigned to the Center for Devices and Radiological Health (CDRH), but it can be more difficult to understand which Center is responsible for a combination product. Primary assignment is based upon the primary mode of action of the combination product. The draft guidance recommends the sponsor contact the Office of Combination Products 1) if they are unsure if the product is a combination product, and 2) to submit a request for designation (RFD) for classification and/or assignment to a center.
The draft guidance describes best practices for interactions between the combination product sponsor and the FDA, including to:
contact the appropriate Center
follow FDA guidance for appropriate communication format (meetings, written, etc.)
communicate in a timely manner and with clear and complete information
ask clear questions to direct the requested feedback
provide appropriate rationale and supporting information
The FDA outlines how it will communicate with the sponsor about the feedback and advice requested. The draft guidance also details what information to include when requesting feedback through either an application-based mechanism or a combination product agreement meeting.
The draft guidance, when approved, will improve and expedite communications between combination product sponsors and the appropriate FDA Center regarding feedback on regulatory or scientific questions. Comment now through February 24, 2020 here.
- The Clinical Pathways Team
Enjoy this blog? Please like, comment, and share with your contacts.