What is the difference between FDA 820 and 13485?

Introduction

In the highly regulated world of medical devices and equipment, compliance with quality management systems is of utmost importance. Two widely recognized standards are FDA 820 and 13485. Both aim to ensure safety, effectiveness, and quality of medical devices. However, there are significant differences between the two standards. This article will explore these differences in detail.

FDA 820 - Quality System Regulation

The FDA 820, also known as the Quality System Regulation (QSR), is a set of regulations established by the U.S. Food and Drug Administration (FDA). It applies to manufacturers selling medical devices in the United States. The main focus of FDA 820 is to establish a comprehensive quality management system that covers various aspects of device manufacturing, including design controls, production, process controls, packaging, labeling, and more.

One key requirement of FDA 820 is the implementation of Design Controls. Manufacturers must document the design and development processes, conduct risk analysis, and validate and verify the design to ensure its safety and efficacy. Additionally, FDA 820 emphasizes the need for proper documentation and record-keeping throughout the entire manufacturing process.

ISO 13485 - International Standard for Medical Devices

ISO 13485 is an internationally recognized standard developed by the International Organization for Standardization (ISO). It provides a framework for establishing, implementing, and maintaining a quality management system specifically tailored to the medical device industry. Unlike FDA 820, ISO 13485 is not specific to any country but is widely adopted around the world.

ISO 13485 places greater emphasis on risk management, customer satisfaction, and regulatory compliance. It requires manufacturers to identify and manage risks throughout the entire product lifecycle. The standard also emphasizes the importance of monitoring customer feedback and implementing effective complaint handling systems. Furthermore, ISO 13485 encourages the use of a process-based approach for quality management, emphasizing continuous improvement and the prevention of non-conformities.

Differences in Scope and Applicability

While both standards focus on ensuring the safety and quality of medical devices, there are key differences in their scope and applicability. FDA 820 is primarily applicable to manufacturers selling medical devices in the United States, whereas ISO 13485 is widely recognized and accepted globally. This means that a manufacturer must comply with FDA 820 to sell their products in the U.S., but ISO 13485 certification can open doors to international markets.

Additionally, FDA 820 covers a broader range of activities and requirements compared to ISO 13485. It includes specific regulations regarding labeling, packaging, and other aspects of device manufacturing. ISO 13485, on the other hand, places more emphasis on risk management, customer satisfaction, and continual improvement.

In Conclusion

In summary, FDA 820 and ISO 13485 are two important quality management systems in the field of medical devices. While both aim to ensure the safety and effectiveness of devices, they have distinct differences in terms of scope and applicability. Manufacturers must carefully evaluate their target markets and regulatory requirements to determine which standard(s) to pursue. Compliance with either of these standards demonstrates a commitment to quality and regulatory compliance within the medical device industry.