Which regulation would apply in addressing the risk management of medical devices?

The regulation that specifically addresses risk management for medical devices is ISO 13485. This standard is part of the ISO 9000 family and is focused on the quality management systems requirements for organizations that design and manufacture medical devices. A crucial aspect of ISO 13485 is its emphasis on risk management throughout the lifecycle of a medical device, which includes identifying, evaluating, and mitigating risks associated with device safety and effectiveness.

ISO 13485 outlines the processes necessary to ensure that medical devices meet customer and regulatory requirements consistently. It provides a framework that supports the implementation of risk management strategies, making it fundamental for manufacturers aiming to maintain compliance and ensure the safety of their products.

While other options address important aspects of medical device regulation, they do not specifically focus on risk management in the same comprehensive manner that ISO 13485 does. For instance, Good Manufacturing Practices (or Quality System Regulations) relate to quality control and assurance processes but are broader in scope. The FDA Modernization Act primarily amended earlier regulations but does not directly address risk management. NIST Guidelines can provide valuable information on risk management principles but are not specific to medical devices. Therefore, ISO 13485 is the most relevant regulation in the context of risk management for medical devices.