What is the difference between FDA 820 and 13485?

When it comes to regulations governing medical devices, two important standards that manufacturers and developers must abide by are FDA 820 and 13485. Despite their similar objectives, there are several key differences between these two standards. This article aims to provide an easy-to-understand explanation of the dissimilarities.

FDA 820: Quality System Regulation

FDA 820, also known as the Quality System Regulation (QSR), is a set of requirements developed by the U.S. Food and Drug Administration (FDA) specifically for medical device manufacturers who wish to distribute their products in the United States.

One of the major focuses of FDA 820 is compliance with Good Manufacturing Practices (GMP). This means that manufacturers must establish and maintain quality management systems that ensure consistency and reliability throughout the entire product lifecycle. It covers various aspects ranging from design and development to production, distribution, and even post-market activities like complaints and recalls.

Under FDA 820, medical device companies are also required to implement rigorous documentation practices. This includes maintaining comprehensive records of processes, procedures, and changes made to the devices throughout their life span. Additionally, they must establish controls for handling non-conforming products and have proper corrective and preventive action plans in place.

13485: International Standard for Quality Management Systems

ISO 13485 is an international standard for quality management systems specifically tailored for medical device manufacturers. Although it has similarities with FDA 820, 13485 has a broader scope and is recognized globally.

Unlike FDA 820, 13485 is not limited to the regulations of a particular country; rather, it provides a framework for organizations to demonstrate their commitment to quality and complies with regulatory requirements in multiple countries. This allows manufacturers to streamline their processes and ensure consistency across various markets.

Additionally, ISO 13485 places a strong emphasis on risk management throughout the entire product lifecycle. This includes proactive identification, assessment, and mitigation of potential risks associated with the development, manufacturing, and use of medical devices.

The Key Differences

While both FDA 820 and 13485 share similarities in terms of quality management requirements, there are several key differences between them:

1. Scope: FDA 820 is specific to the United States, while 13485 has international recognition.

2. Design Control: FDA 820 has more explicit requirements for design control processes compared to 13485.

3. Risk Management: ISO 13485 places greater emphasis on risk management throughout the product lifecycle compared to FDA 820.

4. Documentation: FDA 820 has more stringent documentation requirements compared to 13485.

In conclusion, both FDA 820 and ISO 13485 are crucial standards that medical device manufacturers must adhere to. While FDA 820 focuses primarily on the U.S. market, ISO 13485 provides a broader scope that caters to international compliance. Understanding these differences is essential for companies seeking to navigate the complex landscape of medical device regulations.