The US FDA maintains a Quality System Regulation (QSR), also known as FDA 21 CFR Part 820, which is a document that all medical device manufacturers operating or selling products into the United States market should comply with to ensure their products meet the applicable requirements and specifications at all stages of development. The FDA’s Quality System Regulation (QSR) ensures that all the medical devices produced and sold in the USA are effective for their intended use and assure patient safety.

This Quality Management System (QMS) is the set of policies and procedures and covers aspects like medical device design, manufacturing, product labeling, storage and distribution, supplier management, clinical data, risk management, and complaint handling.

The FDA 21 CFR Part 820 Components

Quality System Requirements: Regulations in this section ensure the safety and effectiveness of the finished product, and consist of information about management responsibility. These include organization structure, quality policy, details of quality representative, quality system procedures, responsibility and authority, quality planning details,  reporting and review provisions, and procedures for quality audits.

Design Controls: This sectional regulation outlines the procedures to follow that make sure the whole design and development process is in accordance with the necessary stipulation. There are several phases to design and development such as planning, input, output, review, verification, validation, production transfer, and changes to the design. After design controls, Design History Files (DHFs) and Device Master Records (DMRs) are created to document compliance with design controls.

Document Controls: These are the regulations that govern the approval, distribution, and modification of documents. As per this section, all documentation generated by a QSR state manufacturer must be reviewed and approved by an authorized person. In addition, a manufacturer should also ensure that everything related to the manufacturing process is accounted for, and ensure that obsolete documents are removed. Besides, changes and amendments to documents must follow the same procedure and be shared on time with the respective authority.

Purchasing Controls: As well as purchasing data, this section includes evaluations of contractors, suppliers, and consultants. Manufacturers are responsible for establishing and maintaining compliance with the received services and products. Every manufacturer must ensure to establish and maintain the compliance of the received products and services. The manufacturer is required to record and maintain purchasing data as well as document the evaluation process and the results so obtained.

Identification and Traceability: In this section, identifying a product means avoiding mix-ups, and tracing them means identifying defects in the product. To avoid this, manufacturers should develop and maintain identification procedures for all stages of the product’s lifecycle, such as production, distribution, receipt, and installation. In order to ensure traceability, each device (a unit, batch, or lot) must be assigned a control number at every stage of manufacturing.

Corrective and Preventive Actions (CAPA): A manufacturer must set up and maintain certain procedures as part of CAPA implementation, including investigation,  analysis, determining the corrective and preventive actions for a recurrence, CAPA verification, and validation, executing and documenting any changes to methods and procedures,  making sure the appropriate individuals within the organization receive the information, submission of necessary data for management review, and the documentation of all the above activities.

Labeling and Packaging Control: Manufacturers are required to follow proper labeling and packaging control procedures to prevent the risk of product mix-up and inappropriate storage and transportation, including labeling inspection and operations, product packaging, as well as shipping containers.

Infographic provided by Antares Health Products, a vitamin E TPGS manufacturer

Conclusion

The FDA 21 CFR Part 820 is designed to assist manufacturers in ensuring that medical devices are compliant with the FDA requirements, and that calls for incorporating all the components into a quality management system to better manage all the sections and consistently produce high-quality products with less chance of mistakes occurring.