21 CFR Part 820 : A Quality System Regulation Guide

Navigating the intricate framework of 21 CFR Part 820, the federal regulation specifically addresses the quality system requirements for the manufacturing, labeling and packaging medical devices intended for human use in the United States. This federal document, enforced by the Food and Drug Administration (FDA) under the Department of Health and Human Services, mandates comprehensive management responsibility, ensuring devices meet the intended use without significant injury risk. It emphasizes the necessity of process validation, preventive action, and corrective action to maintain device quality and safety, aligning with international standards and good manufacturing practice.

In order to bring a medical device to the market, in general, there are two main pillars: the technical documentation regarding the medical device and a quality management system (QMS). Depending on the classification of the medical device, there might be more or less requirements for both to ensure that the finished devices will be safe. In the United States, FDA is the regulatory body that controls and publishes the legislation regarding medical devices. In this article, we explore what are the requirements for a QMS according to the US legislation 21 CFR Part 820.

What is 21 CFR Part 820?

 21 CFR Part 820 means Part 820 of Title 21 of the Code of Federal Regulations. This is a set of regulations by FDA that outlines the current good manufacturing practices with regards to the QMS for medical device manufacturers. The aim of these legal requirements is to ensure that the medical devices that are put on the US market are safe, effective and compliant products. Note that 21 CFR Part 820 only applies to manufacturers of finished devices. The first version of this regulation became effective in December 1978.

What are the FDA Requirements of 21 CFR Part 820?

The requirements laid out in 21 CFR Part 820 are focused on Quality Systems and cGMP requirements. A Quality System or Quality Management System is designed to ensure that the products and services you are providing are in line with regulatory compliance and customer requirements. By converting these requirements into a law, FDA provides a legal framework to ensure manufacturers have a well-structured, repeatable and process-based structure in place to develop compliant devices and services.

Quality audits and process validation are essential to confirm that manufacturing processes are capable of consistently producing finished devices that conform to device specifications and ensure safety and performance. This includes rigorous test equipment and acceptance status evaluations to ensure finished device acceptance. The federal regulation covers electronic code management, specifying that unless otherwise noted, all electronic records and signatures are deemed reliable, trustworthy, and equivalent to paper records.

What are the different parts of 21 CFR Part 11 and their requirements?

The provision of objective evidence is crucial in demonstrating that device specifications meet user needs and intended uses, supported by a robust design history file that documents the design validation and development process. Quality assurance procedures, along with a clear quality policy, establish the foundation for a device quality system that ensures compliance with the federal regulation.

There are 15 sections or subparts within 21 CFR Part 820, each addressing part of the requirements for Quality Systems.

For example: Manufacturers are encouraged to use valid statistical techniques for design and development, facilitating the manufacturing of devices automated to meet specific device requirements. This includes the establishment and maintenance of a quality system that covers all aspects of production, from design to distribution, ensuring that devices are subject to regulatory authority and meet the criteria for safety and effectiveness as outlined in the federal document.

We'll dive into them one by one.

21 CFR Part 820 Part A- General provisions

This section provides the definitions used in the other subparts. It also explains the scope, exemptions and applicability of 21 CFR Part 820. The most important message from this subpart is that 21 CFR Part 820 applies to manufacturers of finished devices, regardless of whether these devices are manufactured in the US, or imported in and intended to be used in the US.

21 CFR Part 820 Part B- Quality system requirements

This subpart describes the Management responsibilities, audit requirements and training requirements. These are general requirements one should consider when implementing a Quality Management System.

Top management needs to ensure resources, policies and communication regarding the Quality System, make sure training is in provided where needed and performance is monitored.

21 CFR Part 820 Part C- Design controls

Subpart C requires to have procedures and controls in place that cover the entire design cycle.

21 CFR Part 820 Part D- Document controls

This subpart focuses on how to approve and distribute documents and how to handle changes in documents. Having proper document control ensures that the correct version of each document is secure and accessible when needed.

21 CFR Part 820 Part E- Purchasing controls

Purchasing controls is focused on supplier management. It gives requirements for supplier evaluation, but as well the purchase control and related daA.

21 CFR Part 820 Part F- Identification and traceability

Identification and traceability is about making sure there is a clear identification of all products throughout all stages of production, distribution and installation, with specific requirements for traceability for implants.

This is very important to ensure that whenever a fault occurs, the user can report it correctly and the manufacturer can take appropriate actions.

21 CFR Part 820 Part G- Production and process controls

Subpart G describes all requirements related to production  and process controls. This is a larger part in the legislation as it touches all different aspects that need to be considered such as:

  • Process Changes

  • Environment

  • Personnel

  • Contamination

  • Buildings

  • Equipment

  • Maintenance

  • Materials

  • Inspections

  • Validation

21 CFR Part 820 Part H- Acceptance activities

This part is all about testing. Acceptance activities include incoming inspection, in-process acceptance and final acceptance. This subpart describes the requirements for all 3 and the expectations in terms of documentation.

21 CFR Part 820 Part I- Non-conforming product subpart

Even though manufacturer take all possible measures to ensure their products are safe and compliant, they need to have procedures in place that guide them on what to do in case a finished product is not conform the requirements and standards. Subpart I describes the need for procedures related to control of nonconforming product and nonconformity review and disposition. This includes identifying nonconforming devices, documenting it, evaluating what went wrong and defining what to do next. Check out our video guide on 21 CFR Part 820.

21 CFR Part 820 Part J- Corrective and preventative action (CAPA) subpart

This subpart describes what should be part of the corrective and preventive actions procedure, It covers the whole CAPA processs, its documentation and the link to other processes, such as management review.

A CAPA process consists of at least :

  • Documenting what was noticed

  • Immediate actions if needed (corrections)

  • Root cause analysis

  • Risk analysis

  • Actions to prevent Recurrence (corrective actions) or occurrence (preventive actions)

  • Planned implementation

  • Effectiveness check of actions

21 CFR Part 820 Part K- Labelling and packaging control subpart

This section outlines what should be implemented to control labeling activities such as ensuring label integrity, labeling inspection, labeling storage, labeling operations and adding control numbers.Furthermore, it requires device packaging to be designed and constructed to prevent damage during processing, storage, handling and distribution.

Both are important to ensure the integrity of the device and its correct identification.

21 CFR Part 820 Part L- Handling, storage, distribution and installation subpart

This subpart requires manufacturers to create procedures regarding handling, storage, distribution and installation of their devices in order to avoid adverse effects to their products.

Quality doesn't stop after the manufacturing of the device and a quality management system should cover the entire life cycle of that device. This part focuses on assuring safety of the devices after manufacturing process and ensuring that individuals handling and installing the devices have clear guidelines on how to do so.

21 CFR Part 820 Part M- Records subpart

The world of medical devices is a very regulated one. Compliance to the applicable regulations is checked through inspection of records. Also in case of FDA inspections, specific records, including device identification need to be made available. Subpart M describes that all required records need to be made available to FDA for review, they need to be legible and there should be a process in place to minimize deterioration and prevent loss. Furthermore, a record retention period needs to be established based on the expected life of the device and not less than 2 years from the date of release for commercial distribution by the manufacturer.

These records include:

21 CFR Part 820 Part N- Servicing

When servicing is a specified requirement, instructions and procedures on how to perform servicing and how to verify it meets requirements need to be established.

The analysis and reporting of service reports need to be described. This process should be linked to complaint handling under the federal title.

21 CFR Part 820 Part O- Statistical techniques subpart

Sampling plans and used statistical techniques need to be described in procedures. Sampling plans need to be describes as well and be based on valid statistical rationale. All activities related to sampling need to be documented.

21 CFR Part 820 outlines the responsibilities of manufacturers, including the requirement to maintain records deemed confidential, manage rework and reevaluation, and ensure additional processing instructions are followed for conformance to design. Each subpart of this comprehensive document ensures that medical devices, whether Class I,II,III devices or those requiring more stringent controls, are manufactured to the highest standards, facilitating their approval and distribution while safeguarding public health. The federal title of this regulation underscores its authority and the subparts within the document guide manufacturers through the various requirements set forth in this essential piece of federal legislation.

What is the difference between ISO 13485 and 21 CFR 820?

Even though both ISO 13485 and 21 CFR Part 820 cover requirements for Quality Management Systems, there are some differences.

First of all, ISO 13485 is a standard, not a regulation. This means that ISO 13485 is not linked to one region of the world and is also not a legal requirement (note that standards are voluntary). ISO 13485 is a global standard that aims to harmonize medical device regulatory requirements for quality management systems. FDA announced their intention to align with the ISO 13485 standard in 2022, but at the time of writing, this has not yet been finalized. 

Next to one being a standard and the other being part of a regulation, there are other differences.

For example:

  • Different documentation

    • ISO 13485 requires a Quality Manual, while 21CFR Part 820 does not

    • 21 CFR Part 820 refers to Device Master Record, Device History Record while this is not mentioned in ISO 13485

    • Bot require management reviews, but the requirements are less defined in 21 CFR Part 820

  • ISO 13485 puts more emphasis on customer focus

  • 21 CFR Part 820 is more explicit about resources and infrastructure.

  • ISO 13485 requirements are not linked to any product classification whereas in 21 CFR Part 820 some are (e.g. Design controls)

For organizations that need to comply to both, it remains important to analyze requirements from both ISO 13485 as well as 21 CFR Part 820 to ensure all requirements are adequately implemented.

Matrix Requiremens for 21 CFR Part 820 Compliance

Looking at all requirements from 21 CFR Part 820 it is obvious that implementing a compliant Quality Management System is not an easy task and is neither a one person's task. This requires the input and engagement from everyone within the organization. Creating and managing a QMS requires to have a full overview of all processes that are covered by it. A software tool can help organizations ensuring that this is the case.

MatrixQMS is a software platform that allows you to create and maintain all procedures and quality records in one place. It provides a means to make a gap analysis against the requirements of 21 CFR Part 820 and allows your whole team to collaborate. By ensuring full control of your documentation, it reduces the time spent on this task and allows employees on value-added activities

Matrix does not consider the QMS to be something that stands alone. Our platform allows RAQA and Engineering to work together by providing both solutions for the QMS as well as Product documentation in one, making sure everything is linked and traceable.

If you would like to explore how MatrixQMS can help you successfully be compliant with 21 CFR Part 820 and ISO 13485, don't hesitate to contact us for a demo!

You can take a look at our video guide on 21 CFR Part 820 here to keep upto date.

About the Author
Ann Vankrunkelsven
RA/QA Manager