Medical device manufacturers in the United States are subject to a strict set of regulations known as 21 CFR Part 820. This Quality System Regulation (QSR) ensures that medical devices are safe and effective for their intended use. The regulation covers various quality management topics, from design controls & product characteristics to complaint files, and requires manufacturers to maintain comprehensive records of their manufacturing processes. In this article, we will look at 21 CFR Part 820 and what it means for medical device companies in the U.S.
What is 21 CFR Part 820?
21 CFR Part 820 is a set of US FDA regulations that define Quality System Regulation (QSR) for medical device manufacturers. It outlines the requirements for the design, production, distribution, and servicing of medical devices. Compliance with 21 CFR Part 820 is essential for medical device companies to ensure the safety and effectiveness of their products.
To whom does FDA 21 CFR Part 820 apply?
The FDA 21 CFR Part 820 applies to all medical device manufacturers located in the United States that are required to register with the FDA and follow current Good Manufacturing Practices (cGMP). This regulation covers medical device manufacturers who produce devices for human use, including custom-made ones. Additionally, this regulation applies to any company that is involved
How to stay compliant with 21 CFR 820
Medical device manufacturers must adhere to the quality system requirements outlined in 21 CFR 820 to ensure that their finished devices meet the established standards for safety and efficacy. To remain compliant, here are the necessary actions to take:
- Develop a Quality Management System (QMS): A QMS is a set of procedures, processes, and policies that support the organization’s objectives. Establishing a QMS that accounts for the requirements of 21 CFR 820 and other applicable regulations will help manufacturers stay compliant.
- Implement Design Controls: Medical device manufacturers must implement design controls to manage the design and development of their finished devices. Design controls help ensure that devices are safe and effective and that they meet their intended use.
- Conduct Quality System Audits: Regular quality system audits can help medical device manufacturers identify areas where they need to improve their quality system and stay compliant with 21 CFR 820.
- Maintain Comprehensive Records: Medical device manufacturers must maintain detailed records to demonstrate compliance with 21 CFR 820. These records should include a Device Master Record (DMR) that contains all the necessary information about designing, producing, and distributing the device, as well as a Device History Record (DHR), which is used to document the device’s manufacturing history.
- Implement Corrective and Preventive Actions (CAPA) Process: The CAPA process helps manufacturers identify the root cause of quality problems, take corrective action, and prevent those problems from occurring in the future. Implementing an effective CAPA process is critical to staying compliant with 21 CFR 820.
- Ensure Proper Labeling and Packaging: Medical device manufacturers must ensure that their devices are properly labeled and packaged, as required by 21 CFR 820. This includes ensuring that labeling and packaging contain all necessary information to identify the device, provide instructions for use, and any warnings or precautions.
- Stay Up-to-Date with Regulatory Changes: Medical device manufacturers must stay informed about changes to the regulatory landscape, including updates to 21 CFR 820, to ensure that they remain compliant with all applicable regulations.
In summary, medical device manufacturers must implement an effective quality management system, design controls, quality system audits, proper documentation, CAPA process, appropriate labeling, and stay informed of changes in regulations to maintain compliance with 21 CFR 820 and other applicable regulations.
What is the difference between ISO 13485 and 21 cfr 820?
For medical device manufacturers, compliance with regulations is of utmost importance. Two major regulations that are widely used in the industry are ISO 13485 and 21 CFR 820. While both regulations cover similar topics and requirements, there are some key differences between the two. In this article, we will explore the differences between ISO 13485 and 21 CFR 820 and how they impact medical device manufacturers.
ISO 13485 is an international standard for medical device quality management systems that was developed by the International Organization for Standardization (ISO) in 2003. The standard specifies requirements for a quality management system that ensures the development, production, and distribution of safe and effective medical devices. The ISO 13485 standard is applicable to all types of medical devices and covers the entire product lifecycle, from design and development to post-market surveillance.
On the other hand, 21 CFR 820, also known as the Quality System Regulation (QSR), is a regulation drafted by the US Food and Drug Administration (FDA). It outlines the requirements for medical device manufacturers operating in the United States. Like ISO 13485, 21 CFR 820 covers a variety of quality management system requirements, including design controls, corrective and preventive actions, production process controls, labeling and packaging, and more.
One of the main differences between the two regulations is their scope. While ISO 13485 is an international standard that applies to all medical device manufacturers, 21 CFR 820 is specific to medical device manufacturers operating in the United States. Additionally, 21 CFR 820 includes several requirements that are not covered by ISO 13485, such as specific requirements for complaint handling and medical device reporting.
Another important difference between the two regulations is their level of specificity. ISO 13485 provides broad guidelines for a quality management system, whereas 21 CFR 820 includes specific requirements that must be met by medical device manufacturers. For example, 21 CFR 820 requires manufacturers to maintain specific records, such as device history records and device master records, which are not explicitly required by ISO 13485.
In conclusion, while ISO 13485 and 21 CFR 820 are both quality management system requirements that aim to ensure the safety and effectiveness of medical devices, there are significant differences between the two. Medical device manufacturers must carefully evaluate their business needs and market requirements to determine which regulation(s) they need to comply with. Additionally, it is important to note that compliance with one does not necessarily guarantee compliance with the other, and separate efforts may be required to meet the requirements of each regulation.
History of FDA 21 CFR Part 820
The history of FDA 21 CFR Part 820 can be traced back to the passage of the Medical Device Amendments of 1976, which amended the Federal Food, Drug, and Cosmetic Act. These amendments gave the US Food and Drug Administration (FDA) the authority to regulate medical devices and set quality standards for manufacturing.
In 1978, the FDA published the first version of 21 CFR Part 820, known as the Good Manufacturing Practices (GMP) regulation for medical devices. This regulation established quality system requirements for manufacturers of medical devices and covered a variety of areas, such as design controls, corrective and preventive actions, and device labeling.
Over the next few decades, the FDA revised 21 CFR Part 820 several times to align it with international quality standards and to address emerging issues in the medical device industry. In 1997, the FDA issued a proposed rule to revise the regulation and improve its clarity and consistency. The final rule was issued in 1996 and included several significant changes such as introducing a risk-based approach to quality system requirements.
In 2002, the FDA issued the first-ever guidance document for 21 CFR Part 820, which provided manufacturers with additional guidance on implementing the regulation. The guidance document covered design controls, corrective and preventive actions, and complaint handling.
Since then, the FDA has continued to revise and update 21 CFR Part 820 to stay current with evolving industry standards and best practices. In 2016, the FDA announced plans to revise the regulation again and proposed several changes to streamline the regulatory process while maintaining patient safety.
Today, 21 CFR Part 820 remains a critical regulation for medical device manufacturers operating in the United States, ensuring the quality and safety of medical devices for the public.