In the realm of pharmaceuticals, medical devices, and biologics, the convergence of technologies has given rise to a unique category of products known as combination products. These products, which combine two or more different types of medical products, often require a nuanced approach to regulatory approval. The FDA’s Request for Designation (RFD) process serves as a critical tool in clarifying the regulatory pathway for combination products. In this blog, we will delve into the significance of the FDA RFD process, its key elements, and how it facilitates the regulatory journey for these complex healthcare solutions.
Combination products are medical products that combine drugs, devices, or biologics in a single entity. Examples include drug-eluting stents, prefilled syringes with drugs, and combination drug-device inhalers. Their unique nature necessitates careful consideration of regulatory pathways.
Given the diverse nature of combination products, determining the appropriate regulatory pathway can be challenging. Is it primarily a drug, a device, or a biologic? The answer to this question is crucial for navigating the regulatory landscape effectively.
This is where the RFD comes into play. The FDA’s Request for Designation process allows sponsors to obtain the agency’s official determination of the primary mechanism of action (PMOA) of a combination product. The PMOA guides the selection of the lead FDA center responsible for regulating the product.
Benefits of submitting an RFD request includes gaining clear regulatory designation, streamlining the development and approval process. Additionally, an RFD facilitates early communication with the FDA, fostering collaboration and alignment on regulatory requirements.
The RFD process begins with the formal RFD submission. Sponsors submit an RFD to the FDA, and the agency reviews the information to determine the product’s primary mode of action. This process is typically completed within 60 days of submission.
Based on the information provided, which includes an analysis on what the sponsor believes is the PMOA, the FDA issues a determination letter that identifies the lead center for regulatory oversight. The lead center may be the Center for Drug Evaluation and Research (CDER), the Center for Devices and Radiological Health (CDRH), or the Center for Biologics Evaluation and Research (CBER).
The FDA’s Request for Designation process plays a pivotal role in providing regulatory clarity for combination products, facilitating a smoother path to market. As innovation in healthcare continues to yield increasingly complex products, the RFD process serves as a crucial mechanism for collaboration between sponsors and regulatory authorities.
EMMA International can help you prepare and submit an RFD to gain regulatory clarity on your product. Call us at 248-987-4497 or email info@emmainternational.com to get in touch with our team of experts today.
