Countdown Begins: Preparing for FDA’s Amended Quality Management System Regulations (QMSR) Final Rule

On January 31, 2024, the US Food and Drug Administration announced an amendment to 21 CFR 820 concerning current good manufacturing practice (CGMP) for device manufacturing as part of its efforts to harmonize its regulations with other regulatory authorities. This amendment aligns more closely with the International Organization for Standardization, ISO 13485:2016, which is very similar to QS regulation in assuring the safe and effective manufacturing of devices. It will also ensure that the quality management system remains compliant with the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The title of the regulation has been amended as Quality Management System Regulation (QMSR) to reflect the additional requirements that match the ISO 13485 concepts and expectations. The amendment made to part 4 (21 CFR part 4) will not create inconsistencies with other applicable regulations or impact the CGMP requirements for combination products.

As part of the harmonization efforts, the FDA has been doing the following:

• Update its information technology systems
• Train FDA staff assessing compliance with the requirements of the medical device quality management system
• Develop an inspection process
• In addition to revising relevant regulations, also revise document requirements necessary for the new regulation
• Communicate and educate stakeholders about the changes and the impact

The rule will become effective in two years, on February 2, 2026. The device manufacturers will be required to comply with the existing QS regulation for the time being but start preparing for the new requirements when they become effective.

Key Requirements of the Amended Regulations

Some of the key requirements of the new QMSR include:

• Document Compliance: Certain class I, class II, and class III device manufacturers must ensure the compliance of documents related to the quality management system (QMS) 820.10 with any applicable ISO 13485 requirements.
• Traceability: Life-saving device manufacturers must ensure compliance with the requirements for Traceability of Implantable Devices (clause 7.5.9.2 in ISO 13485).
• Control of Records: Section 820.35 covers requirements for record signature and date, documentation to meet requirements for Unique Device Identification (UDI), and mandatory information as per Part 803, such as specific servicing activities and complaint records. Manufacturers must also comply with clause 4.2.5 in ISO 13485, by providing a definition of the records included in the quality management system and specifying how they are controlled.
• Device Labeling and Packaging Controls: A labeling and packaging clause has been added to Part 820 of the QMSR. Section 820.45 mandates a detailed description of the packaging and labeling activities undertaken to strengthen the controls for these processes.

How to prepare for QMSR Final Rule Compliance

Some of the key areas where the QMSR implementation will need work for manufacturers of medical devices include:

Risk Management

The standard increases the emphasis on risk identification, analysis, evaluation, control, and monitoring throughout the product life cycle to ensure the safety and effectiveness of the devices. A risk-based approach must be adopted through the product life cycle, right from design, development, traceability, purchase, and testing to installation and servicing.

Communication Management

The communication SOP to customers regarding the correction or removal of products must comply with 21 CFR Part 806 Medical Devices.

Design Control

Design controls must be applied to class II, class III, and certain class I devices. It requires a review of any individual(s) who do not have direct responsibility for the design stage reviewing the design.

Unique Device Identifier

The unique device identifier (UDI) for each medical device or batch of medical devices must be recorded in the device history record (DHR).

Labeling and Packaging

The accuracy of labeling and packaging must be reviewed prior to the release or storage of the product. It should include the correct UDI or other device identification(s), the date of expiry, storage and handling instructions.

Servicing Documentation

This is also part of the new requirements where all details related to servicing activities must be recorded, including the UDI or other device identification(s), the date of service, the service engineer, the nature of service, and any test or inspection data.

Traceability

This should comply with the requirements of 21 CFR Part 830 Unique Device Identification and 21 CFR Part 821 Medical Device Tracking Requirements.

Complaints Handling

21 CFR Part 803 Medical Device Reporting requires that complaints be investigated and reported to the FDA, capturing information such as name and identification of the device, the date the complaint was received, the complainant details, the nature and details of the complaint, corrective action taken, and the reply given.

ComplianceQuest EQMS for QMSR Compliance

ComplianceQuest is a cloud-based Quality Management System that is aligned with ISO standards, enabling businesses to comply quickly and easily. The QMS includes features that can empower businesses to adapt to the new requirements of the QMSR on the go. Some of the key features that enable this include:

• Document Management: This can help businesses create templates to meet the new requirements for documentation of processes and provide accurate packaging and labeling information. Since the document lifecycle can be automated from creation to archiving based on regulatory requirements, it reduces the burden on the resources, allowing them to focus on the core aspects of their functions.
• Risk Management: The CQ QMS enables a risk-based approach to quality management, helping with risk identification, analysis, rating, prioritization, and implementing controls.
• Change Management: The manufacturers need a robust change management system to identify gaps between the existing system and the upgraded system. Based on this gap, they can create a strategy to plan the changes required, the implementation, impact analysis, and so on for efficiency and effectiveness.
• Design Controls and Traceability: ComplianceQuest also has a product lifecycle management suite with design controls and requirements traceability matrix solutions to manage the new requirements and improve compliance.
• Training Management: The training feature of the CQ QMS can enable leaders to identify gaps in knowledge to meet the new requirements and provide focused training in quality management, inspection, audits, and so on to equip the employees with the required skills.

To know more about the ComplianceQuest EQMS, visit: www.compliancequest.com