The FDA has recently released a draft guidance on Use-Related Risk Analyses (URRAs) for drugs, biological products, and combination products. This new guidance consolidates previously available information into one comprehensive document, making it easier for industry stakeholders to access and apply the guidelines effectively.

KEY HIGHLIGHTS OF THE GUIDANCE:

1. Purpose: The guidance aims to explain identifying use-related hazards and implement measures to reduce associated risks. This is crucial for ensuring that medical products are safe and effective for their intended users.
2. Scope: The guidance is applicable to drugs, biological products, and combination products. This broad scope ensures that a wide range of products are covered, promoting consistency in risk management practices across different types of medical products.
3. Process: URRAs should be initiated early in product development and updated throughout the product lifecycle. This proactive approach helps in identifying potential risks early and allows for timely mitigation strategies.
4. Consolidation: This guidance combines previously available information into one comprehensive document, streamlining the process for stakeholders. This consolidation helps in reducing confusion and ensures that all relevant information is easily accessible.

WHY THIS MATTERS:

The new guidance ensures the safety and effectiveness of medical products by helping to determine the need for Human Factors (HF) study results in new marketing applications. By identifying and mitigating use-related risks early in the product development process, companies can enhance the overall safety and usability of their products. This not only protects end-users but also helps companies avoid costly recalls and redesigns.

KALEIDOSCOPE'S EXPERTISE:

At Kaleidoscope Innovation, we specialize in Human Factors for medical products, and have already integrated FDA guidance's into our process. Our team of experts interprets the guidance and applies it directly to your FDA submissions, ensuring you meet the latest requirements. Our HF team works closely with our regulatory team to help you understand the complexities of the regulatory landscape and provide tailored solutions to meet your specific needs.

HOW WE CAN HELP:

• Interpretation: Our experts can help you understand the nuances of the new guidance. We provide detailed explanations and practical insights to ensure you fully grasp the requirements.
• Application: We assist in applying the guidance to your product development and FDA submissions. Our team can help you develop comprehensive Use-Related Risk Analyses (URRAs) that meet FDA standards.
• Compliance: Ensure your products meet the latest FDA requirements with our comprehensive consulting services. We offer ongoing support to help you stay compliant throughout the product lifecycle.