RFD and Pre-RFD submissions

Combination products encompass a diverse range, including drug and device combinations, biological product and device combinations, drug and biological product combinations, and those involving drugs, devices, and biological products. The intricacies of these combinations often challenge traditional regulatory distinctions, necessitating a specialized approach.

The evolving healthcare landscape has witnessed a surge in innovative combination products, posing unique challenges in regulatory processes. Combination products, integrating drugs, devices, or biologics, fall into distinct categories and can be marketed individually or bundled. The US FDA, through the Office of Combination Products (OCP), addresses regulatory ambiguities and determines the regulating center using Request for Designation (RFD) or Pre-Request for Designation (Pre-RFD) submissions. Ambiguities in regulatory oversight arise when products challenge distinctions between drugs, biologics, and devices, prompting the need for specialized regulatory processes. OCP is tasked with resolving regulatory uncertainties. RFD and Pre-RFD submissions are instrumental in determining the appropriate regulatory pathway.

Manufacturers seeking clarity on regulatory pathways can utilize the Pre-RFD or RFD processes to identify the lead center responsible for pre-market review submissions. OCP assigns review responsibilities based on the “primary mode of action” of the product, guided by Section 503(g)(1) of the Federal Food, Drug, and Cosmetic Act.

What is Request for Designation (RFD)?

The Request for Designation is a formal process by which sponsors seek the FDA’s determination of the appropriate regulatory pathway for their product. This is particularly relevant for combination products, which may fall under different regulatory centers within the FDA. The Pre-RFD Meetings provide an informal opportunity for sponsors to discuss potential designations with the FDA before formally submitting an RFD or the product submission. These meetings aim to enhance communication and ensure that the submission is well-prepared and aligned with FDA expectations.

Key Components of RFD:

• Product Description: A comprehensive and detailed description of the product, its components, and intended use.
• Primary Mode of Action (PMOA): Identification of the primary mode of action, a critical factor in determining the lead FDA center.
• Proposed Action:The sponsor’s recommendation for the primary mode of action and the lead center.
• Supporting Information: Any additional data or information supporting the proposed designation.

Significance of RFD :

• Early Engagement with US FDA 
• Clarification on US FDA Expectations 
• Interactive Discussion between US FDA and the Submitter
• Clarity in Regulatory Pathway avoiding delays and uncertainties during the submission 
• Enhanced Communication
• Optimized Resource Allocation for efficient and streamlined regulatory journey.

Empowering Your Regulatory Journey: 8C Healthcare’s Expertise in RFD and Pre-RFD Meetings with the US FDA

Embarking on the regulatory pathway with the U.S. Food and Drug Administration (FDA) demands precision, strategic planning, and effective communication. 8C Healthcare emerges as your trusted partner, offering specialized services in Request for Designation (RFD) and Pre-RFD Meetings with the FDA. 

8C Healthcare’s Regulatory Services:

• Tailored RFD Submissions: Our team of regulatory experts at 8C Healthcare is adept at crafting comprehensive RFD submissions tailored to the unique attributes of your product. From meticulous product descriptions to identifying the primary mode of action, we ensure your RFD stands out for its clarity and completeness.
• Strategic Proposal: We guide you in formulating a strategic proposal for the primary mode of action and the lead center, increasing the chances of FDA alignment with your recommendations.
• Supporting Information Compilation: With a keen understanding of the FDA’s expectations, we assist in compiling all necessary supporting information, presenting a compelling case for your product’s regulatory classification.
• Early Engagement Strategy: 8C Healthcare adopts an early engagement strategy, initiating Pre-RFD Meetings to open communication channels with the FDA before the formal RFD submission. This proactive approach allows us to address potential concerns and align expectations.
• Interactive Discussions: Our team facilitates interactive discussions during Pre-RFD Meetings, ensuring a collaborative environment where questions are addressed, and concerns are proactively handled.
• Risk Mitigation: By leveraging our experience in Pre-RFD Meetings, we help identify and mitigate potential risks early in the process, refining your submission for optimal outcomes.

Why Choose 8C Healthcare?

• Regulatory Prowess: With a team of seasoned regulatory experts, 8C Healthcare brings a wealth of experience in navigating the complexities of FDA regulations. Our in-depth knowledge ensures a smooth regulatory journey for your products.
• Tailored Strategies: We understand that each product is unique. Our regulatory strategies are meticulously crafted to align with the specific attributes of your medical devices, combination products, or digital health devices.
• Proactive Approach: At 8C Healthcare, we believe in a proactive approach to regulatory compliance. Our early engagement strategies in Pre-RFD Meetings set the stage for a positive and collaborative relationship with the FDA.
• End-to-End Support: From initial regulatory planning to submission preparation and post-submission support, 8C Healthcare offers comprehensive end-to-end regulatory services, ensuring a seamless and efficient process.

Choose 8C Healthcare as your regulatory partner to ensure your products navigate the FDA regulatory pathway with precision, efficiency, and success.