In this article, you are going to learn about the regulatory procedure for combination products in the US. What is RFD what are the timelines for it and what role of the Office of Combination products? Combination products as discussed in the article are medicinal products that combine drugs, devices, and or biologics. The regulatory procedure for combination products is regulated by the FDA via the Office of Combination Products.

Office of Combination Products (OCP)

The Office of Combination Products is involved in streamlining the regulatory process for combination products and some of its vital functions include

• 1. Determining the primary mode of action of a combination product, if it is a drug then the review is by CDER, if a biologic lead review is by CBER, or if it is a device then lead review is by CDRH.
• Identify the lead review for combination product using the assignment algorithm
•  OCP is involved in developing policies and guidance documents to address the unique regulatory challenges associated with combination products.
•  Assisting sponsors in regulatory pathways and requirements.

Request for Designation (RFD) to OCP

If you are unable to know the regulatory classification for your combination product you can submit a request for designation to the office of combination products. and the RFD involves submission, review by OCP, and assignment of lead center.

• Assignment of lead center is based on the primary mode of action. office of combination products uses the assignment algorithm for determining the lead review center
• if the primary mode of action of combination product is DRUG – CDER / DEVICE – CDRH / biologic -CBER, if unable to decide Primary mode of action, then algorithm looks for which center has regulated similar combination products most and assigns based on that, if not then which center has more expertise is considered.
• RFD timelines
• Upon submission OCP confirms the receipt of RFD
• review period will be 60 days
• Once the office of combination products issues the designation, the sponsor has to legally bind to it
• There is also an option for Pre-RFD meeting with the OCP to clarify sponsor doubts and submit a well-tailored RFD application.