Difference Between ISO 13485 and 21 CFR 820: Key Distinctions in Medical Device Quality Standards

The difference between ISO 13485 and 21 CFR 820 lies in their scope and approach to medical device quality management. ISO 13485 is an international standard focusing on risk-based quality management, emphasizing global compliance, risk management, and post-market surveillance. In contrast, 21 CFR 820 is a U.S.-specific FDA regulation focused on device safety and effectiveness in the U.S. market. While both require strong documentation and design controls, ISO 13485 takes a broader approach, while 21 CFR 820 emphasizes corrective actions and FDA compliance. Understanding these differences is essential for companies navigating both U.S. and international requirements. Read on to explore these distinctions in more detail.

ISO 13485 is an international standard, while 21 CFR 820 is a regulation specific to the United States. ISO 13485 focuses on quality management systems for medical device manufacturers worldwide. 21 CFR 820, on the other hand, is enforced by the U.S. Food and Drug Administration (FDA) and applies to devices sold in the U.S. market.

The two standards have different scopes and requirements. The ISO 13485 certification requirements provide a more flexible approach, allowing companies to tailor their quality systems to their specific needs. 21 CFR 820 is more prescriptive, with detailed requirements for various aspects of the quality system. Understanding these differences is crucial for medical device companies operating in global markets.

Key Takeaways about the difference between ISO 13485 and 21 CFR 820

• ISO 13485 is international, while 21 CFR 820 is specific to the U.S. market
• The standards differ in their scope and flexibility of implementation
• Companies must comply with both standards to sell medical devices globally

Overview Video – Difference between ISO 13485 and 21 CFR 820

ISO 13485 and FDA 21 CFR Part 820 are key standards for medical device quality management systems. They set rules for how companies design, make, and sell medical devices. These standards aim to keep patients safe and ensure products work well.

ISO 13485:2016 Requirements and Specifications

ISO 13485:2016 is a global standard for medical device quality management. It focuses on risk management and safety. The standard covers all stages of a product’s life cycle.

Key areas include:

• Design and development
• Production and service
• Risk management
• Resource management
• Customer focus

Companies must show they meet customer and regulatory needs. They also need to manage risks and keep improving their systems.

FDA 21 CFR Part 820 Explained

FDA 21 CFR Part 820 is a U.S. regulation for medical device quality systems. It sets rules for how companies make and sell devices in the U.S. The FDA checks if companies follow these rules.

Main points of the regulation:

• Design controls
• Production and process controls
• Corrective and preventive actions
• Management responsibility
• Device history records

Companies must prove their devices are safe and work as intended. They need to keep good records and fix problems quickly. The FDA can inspect facilities to check compliance.

Quality Management Systems Considerations

ISO 13485 and 21 CFR 820 both focus on quality management systems for medical devices. They share some key elements but differ in certain areas of documentation and control.

Difference Between ISO 13485 and 21 CFR 820 – Commonalities in QMS Requirements

Both standards aim to ensure safe and effective medical devices. They require companies to set up quality management systems with documented procedures. These systems must cover design controls, risk management, and production processes.

ISO 13485 and 21 CFR 820 call for internal audits to check if the QMS is working well. They also stress the need for continuous improvement.

Training is important in both standards. Companies must make sure their staff knows how to do their jobs properly.

Both require careful control of documents and records. This helps track changes and keep important info safe.

Divergences in Documentation and Control

ISO 13485 tends to be more flexible than 21 CFR 820 in some areas. It allows companies to decide which processes need more detailed documentation.

21 CFR 820 has stricter rules about device history records. It wants more info about each batch of devices made.

Risk management is a bigger focus in ISO 13485. It asks for risk-based thinking throughout the QMS.

ISO 13485 gives more details on outsourced processes. It explains how to control work done by other companies.

21 CFR 820 has extra rules for some types of devices. These include rules for tracking certain high-risk products.

Product Development and Approval Process

ISO 13485 and 21 CFR 820 have key differences in how they approach product development and regulatory approval. These differences impact design controls and the paths medical device manufacturers must take to gain FDA approval.

Design Control Differences

ISO 13485 and 21 CFR 820 both require design controls, but their approaches vary. ISO 13485 focuses on risk management throughout the design process. It asks manufacturers to identify and mitigate risks at each stage.

21 CFR 820 puts more emphasis on design validation. This means testing the final product to make sure it meets user needs. The FDA requires more detailed documentation of design activities.

Both standards call for design reviews, but 21 CFR 820 is more specific about when these should happen. It also demands more formal design transfer processes when moving to production.

Pathways to FDA Approval

For FDA approval, medical device makers must follow specific pathways based on their product’s risk level. Low-risk devices may use the 510(k) process, showing they’re similar to existing approved devices.

Higher-risk devices often need premarket approval (PMA). This requires clinical trials and more extensive safety data. The FDA also has a de novo pathway for novel low to moderate-risk devices.

ISO 13485 certification doesn’t guarantee FDA approval, but it can help. Companies following ISO 13485 often find it easier to meet FDA requirements. They may need to add some extra steps to fully comply with 21 CFR 820.

Risk Management and Post-Market Activities

ISO 13485 and 21 CFR 820 differ in their approaches to risk management and post-market activities. These differences impact how medical device companies handle product safety and respond to issues after devices are on the market.

ISO 14971 and Risk Management

ISO 13485 requires companies to use ISO 14971 for risk management. This standard gives a step-by-step process to find and lower risks. It covers the whole product lifecycle, from design to disposal.

21 CFR 820 doesn’t mention ISO 14971 directly. But it does require risk analysis during design. The FDA expects companies to use risk-based thinking throughout their quality system.

Both rules want companies to lower risks as much as possible. ISO 13485 is more detailed about how to do this. It asks for ongoing risk management, even after a device is sold.

Difference Between ISO 13485 and 21 CFR 820 – Surveillance and Reporting

Post-market surveillance is key in both systems. ISO 13485 calls for a way to collect and review product experience data. This helps find new risks or problems quickly.

21 CFR 820 has specific rules for complaint handling and reporting. It requires a formal system to track and investigate complaints. Companies must report certain issues to the FDA.

Both systems require corrective and preventive actions (CAPA) for problems. 21 CFR 820 gives more details on how to handle recalls if needed.

ISO 13485 focuses on using post-market data to improve products. 21 CFR 820 emphasizes reporting issues to regulators and taking quick action to protect patients.

Supplier and Procurement Considerations

Supplier management is a key part of both ISO 13485 and 21 CFR Part 820. These standards set rules for how medical device companies work with suppliers.

Managing Suppliers under ISO 13485

ISO 13485 requires companies to pick and watch suppliers carefully. They must check supplier skills and past work. Companies need to set clear rules for suppliers. These rules cover things like product quality and on-time delivery.

ISO 13485 also asks for regular supplier reviews. This helps catch problems early. Companies must keep records of these reviews. If issues come up, they need to work with suppliers to fix them.

The standard pushes for open talks between companies and suppliers. This helps both sides understand what’s needed. It also makes it easier to solve problems quickly.

Supplier Controls in 21 CFR Part 820

21 CFR Part 820 has strict rules for supplier control. It says companies must check supplier products and services. This checking should match the risk of the product or service.

The regulation asks for written agreements with suppliers. These spell out quality requirements. They also say how companies will check supplier work.

Companies must keep good records of supplier performance. If a supplier doesn’t meet standards, the company must take action. This might mean more checks or finding a new supplier.

21 CFR Part 820 also requires companies to audit key suppliers. These audits help make sure suppliers follow quality rules. They also help find ways to improve.

Training and Internal Procedures

Training and internal procedures are key parts of quality systems for medical devices. Both ISO 13485 and 21 CFR 820 have rules about staff training and internal processes.

ISO Training Requirements

ISO 13485 requires companies to train staff who affect product quality. This includes workers involved in making, testing, and handling medical devices. Companies must:

• Keep records of employee training • Make sure staff know their roles and how they impact quality • Assess if training works and take action if needed

ISO 13485 also calls for regular internal audits. These check if quality processes are working well. Trained auditors look at different parts of the company. They write reports on what they find.

FDA Staff and Manufacturer Training

The FDA’s 21 CFR 820 has similar training rules. It says medical device makers must:

• Train all staff who do tasks affecting quality • Document this training • Make sure employees understand how their work impacts device quality

The FDA also trains its own staff. This helps them inspect medical device companies better. FDA inspectors learn about:

• New medical technologies • Quality system requirements • How to spot problems during inspections

Both ISO and FDA rules stress ongoing training. This keeps staff skills up to date as technology changes.

Regulatory Inspections and Audits

ISO 13485 and 21 CFR 820 have different approaches to audits and inspections. The processes aim to ensure medical device companies follow quality standards and regulations.

ISO Audit Procedures

ISO audits focus on evaluating a company’s quality management system. These audits check if the system meets ISO 13485 requirements. Certified auditors conduct the reviews.

Audits happen at set times. They look at company records and processes. Auditors interview staff and observe operations. They check if the company follows its own procedures.

ISO audits aim to find areas for improvement. They help companies maintain their certification. Audit findings can lead to corrective actions. These actions help companies get better over time.

FDA Inspections of Facilities

FDA inspections are different from ISO audits. The FDA can show up at any time. They don’t always give notice. These inspections check if companies follow 21 CFR 820 rules.

FDA inspectors review records and processes. They look at product quality and safety. Inspectors may take samples for testing. They can also interview employees.

If inspectors find problems, they issue Form 483. This form lists observations that need fixing. Companies must respond with a plan to correct issues. Serious problems can lead to warning letters or other actions.

Harmonization Efforts

The medical device industry is moving towards aligning quality system standards globally. This push aims to streamline regulations and improve product safety across markets.

Global Medical Device Standards

ISO 13485 has become a key international standard for medical device quality systems. Many countries now accept or require ISO 13485 certification. The standard provides a framework for consistent quality practices worldwide. It covers areas like risk management, design controls, and supplier oversight.

The FDA has recognized ISO 13485:2016 as a consensus standard. This means manufacturers can use it to meet certain U.S. regulatory requirements. However, the FDA still maintains its own quality system regulation in 21 CFR 820.

Regulatory Bodies Collaboration

Regulatory agencies are working together to align quality system requirements. The FDA plans to update 21 CFR 820 to match ISO 13485:2016 more closely. This project is called the Quality Management System Regulation (QMSR).

The QMSR aims to reduce duplicate audits and inspections. It should make it easier for companies to sell devices in multiple countries. The FDA published a proposed rule in 2022 and a final rule in 2024. These changes will impact how medical device companies operate their quality systems.

Identifying and Recording Information

Proper identification and record-keeping are key aspects of medical device regulations. These practices help ensure product safety and traceability throughout the manufacturing process.

Importance of Device Identification

Unique Device Identification (UDI) is crucial for medical devices. It allows tracking of products from production to patient use. UDI systems help with recalls and adverse event reporting.

ISO 13485 and 21 CFR 820 both require clear product identification. This includes labeling with lot numbers, serial numbers, and expiration dates. Proper identification helps maintain product quality and safety.

Manufacturers must have systems to track device components and materials. This aids in identifying potential issues quickly.

Recording Device History

Device History Records (DHRs) document each unit or batch of devices made. They include key information about the manufacturing process.

DHRs contain details like:

• Date of manufacture
• Quantity produced
• Inspection results
• Any deviations from standard procedures

Both ISO 13485 and 21 CFR 820 require thorough DHRs. These records help ensure consistency in production and aid in quality control.

Batch records are part of the DHR system. They document specific production runs and any special processes used.

Good record-keeping practices support the overall quality management system. They provide evidence of compliance with regulations and standards.

Future Perspectives on Quality Compliance

Quality standards and regulatory compliance in the medical device industry are set to evolve. Changes aim to boost product safety, improve customer satisfaction, and streamline processes for manufacturers.

Improvement in Quality Standards

ISO 13485 and 21 CFR 820 will merge into a single standard by 2026. This change will create a more unified approach to quality management. The new standard will focus on risk management and data-driven decision making.

Medical device makers will need to update their quality systems. They’ll have to train staff on new requirements. The goal is to produce safer, more effective devices.

Continuous improvement will be a key theme. Companies will need to show they’re always working to enhance their processes and products.

Next Steps for Regulatory Compliance

The FDA is moving towards a global approach to device regulation. This shift will help reduce barriers to international trade. It will also make it easier for companies to sell their products in different markets.

Regulators will likely increase their focus on post-market surveillance. This means tracking device performance after it’s sold. Companies will need robust systems to collect and analyze real-world data.

Digital tools will play a bigger role in compliance. Electronic quality management systems will become the norm. These systems will help companies track and manage regulatory requirements more efficiently.

Frequently Asked Questions

ISO 13485 and 21 CFR 820 both set standards for medical device quality management systems. They have key differences in their requirements and approaches.

What are the main differences in the quality management system requirements of ISO 13485 versus 21 CFR 820?

ISO 13485 is an international standard, while 21 CFR 820 is a U.S. regulation. ISO 13485 focuses on a process approach, emphasizing continuous improvement.

21 CFR 820 is more prescriptive, with specific requirements for each aspect of the quality system. It places greater emphasis on design controls and corrective actions.

How do the documentation requirements compare the difference between ISO 13485 and 21 CFR Part 820?

Both standards require thorough documentation, but their approaches differ. ISO 13485 allows more flexibility in document structure and format.

21 CFR 820 has more specific requirements for certain documents, like device master records and device history records. It also mandates signature requirements for key documents.

In what ways do the risk management principles of ISO 13485 differ from those outlined in 21 CFR 820?

ISO 13485 puts a stronger emphasis on risk management throughout the product lifecycle. It requires a documented risk management process for all stages of product realization.

21 CFR 820 addresses risk mainly in design controls and corrective actions. It does not mandate a comprehensive risk management system like ISO 13485.

What are the implications of FDA’s harmonization efforts with ISO 13485 on compliance with 21 CFR 820?

The FDA is working to align 21 CFR 820 more closely with ISO 13485. This aims to reduce regulatory burden and promote global consistency in quality standards.

Companies may find it easier to comply with both standards as they become more aligned. The changes may require updates to existing quality systems and procedures.

Can a medical device company be compliant with both ISO 13485 and 21 CFR 820 simultaneously, and what are the challenges?

Yes, a company can comply with both standards at the same time. Many companies already do this to meet global regulatory requirements.

Challenges include managing different documentation styles and addressing specific requirements unique to each standard. Companies may need separate procedures for some processes.

How does adherence to ISO 13485 facilitate compliance with the FDA’s Quality System Regulation according to 21 CFR 820?

Following ISO 13485 can help meet many 21 CFR 820 requirements. Both standards share similar principles and goals for quality management.

ISO 13485 compliance can provide a strong foundation for 21 CFR 820 compliance. Companies still need to address FDA-specific requirements not covered by ISO 13485.