21 CFR Part 820 vs ISO 13485(2016) Differences and Similarities

Article Context:

1. FDA 21 CFR Part 820 (vs) ISO 13485 (2016)
2. Similarities between FDA 21 CFR Part 820 and ISO 13485 (2016)

ISO 13485:2016 is an international standard for medical device manufacturers and providers of quality management systems. ISO 13485:2016 is not a law or regulation and is voluntary, while FDA 21 CFR Part 820 is mandatory for medical device distribution in the United States.

Major updates of 21 CFR 820 are incorporated in ISO 13485:2016 standard. Therefore, organizations conforming to the ISO 13485:2016 standard can confidently move towards compliance with the FDA 21 CFR Part 820 Quality System Regulation. With compliance to the 21 CFR Part 820 subject regulation, manufacturers and providers can commercially market their medical devices in the USA. In addition, 21 CFR Part 820 specifies requirements for the quality management system to comply with CGMP (Current Good Manufacturing Practices).

ISO 13485:2016 and FDA 21 CFR Part 820 are correlated based on their scope, impact, and application on each other. The points discussed below will help you understand the differences and similarities between both FDA 21 CFR Part 820 and ISO 13485 (2016) standards.

Differences between FDA 21 CFR Part 820 and ISO 13485 (2016)

21 CFR Part 820 and ISO 13485:2016 are quality management system standards that govern medical device design, development, production, and distribution. The fundamental differences between both are discussed below.

Risk Management Perspective

A risk-based strategy is prioritized by ISO 13485 (2016), which also refers to related standards like ISO 14971 for managing medical device product risk management. Seldom are standards for risk management outlined in FDA Part 820.

Regulatory Requirements

The widely recognized ISO 13485 QMS software standard provides a method for adhering to general regulatory requirements. However, FDA 21 CFR Part 820 compliance is only a U.S. rule; other nations have their laws.

Documentation Requirements

ISO 13485 requires manufacturers to establish a quality manual that defines the quality management system, whereas 21 CFR Part 820 does not require a quality manual. Additionally, 21 CFR Part 820 includes specific documentation requirements for Device Master Records, Device History Records, and Design History Files.

Updates for the Compliance

Several updates have been made to the ISO 13485 standards. However, since 1997, the QSR structure has remained the same.

System Requirements

While ISO 13485 Clauses are standard, it does not require a Quality Management System to have a certain documentation format. However, the organization chooses how to handle numerous needs that must be addressed. Although the FDA does not mandate that businesses use a certain documentation system, all documentation requirements must be met. Yet, companies that serve the U.S. market wish to build up a Part 820-compliant documentation system to make auditing easier.

Design and Development

Both standards have specific requirements related to the design and development of medical devices. For example, ISO 13485 emphasizes design inputs and outputs. In addition, it requires that design verification and validation activities be performed throughout the design and development process. 21 CFR Part 820 includes requirements for design controls. Still, the requirements are less specific than those in ISO 13485.

Post-Market Surveillance

ISO 13485 requires manufacturers to establish and implement a post-market surveillance system to monitor the performance of their devices in the market. FDA 21 CFR 820 also includes post-market surveillance requirements, but they are less prescriptive than ISO 13485.

Quality System Audits

ISO 13485 requires internal audits to be conducted at planned intervals to determine whether the quality management system conforms to the requirements of the standard or not. 21 CFR 820 also requires internal audits but does not specify the frequency or scope of the audits.

Criteria for Compliance

The firm makes an internal effort to comply with the ISO 13485 standard to satisfy customers and foster confidence. In addition, the government has set an external criterion for FDA 21 CFR Part 820 compliance in the U.S. market.

Quality Requirements

ISO 13485 is an accepted international standard rather than a directive, rule, or law. A mandatory quality system requirement for the American medical device market is FDA 21 CFR Part 820.

Similarities between FDA 21 CFR Part 820 and ISO 13485 (2016)

Despite the differences, there are also similarities between the two standards, 21 CFR 820 and ISO 13485 (2016):

Focus on Quality Management System

Both standards require medical device manufacturers to establish and maintain a quality management system (QMS) that meets their requirements.

Management Responsibility

Both standards require top management to demonstrate their commitment to the QMS, including providing adequate resources and ensuring that the QMS is effectively implemented and maintained.

Document Control

Both standards require establishing and maintaining document control procedures, including document approval, revision, and distribution.

Corrective and Preventive Actions (CAPAs)

Both standards require establishing and implementing corrective and preventive action (CAPA) procedures to address nonconformances and prevent their re-occurrence.

Supplier Control

Both standards require establishing and maintaining procedures for controlling suppliers, including supplier selection, evaluation, and monitoring.

Personnel Training

For both standards, trained and qualified personnel is required to perform the tasks.

Process Validation

In both standards, processes need to be validated to ensure and produce better quality that meet intended requirements.

Conclusion

Overall, both 21 CFR 820 and ISO 13485 aim to ensure that medical devices are safe and effective for their intended use by establishing and maintaining a robust quality management system.

Common regulatory ideas are included in the current ISO 13485 software's standards. Based on this standard, organisations can work towards the FDA 21 Code of Federal Regulation (CFR) Part 820 compliance (Quality System Regulation). Organizations are permitted to commercially advertise medical gadgets in the U.S. if they follow this law. Part 820 specifies what is needed for the quality system to comply with current good manufacturing practices (GMP) or FDA rules. Regarding requirements, ISO 13485 Quality Management System is a better comparison. Other parts include topics like (for instance) Part 810, which is dedicated to the process of medical device recall, and Part 830, which is dedicated to identifying medical devices using unique identifiers.