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The US Food and Drug Administration (FDA) is responsible for regulating medical devices marketed in the United States.
To ensure the safety and effectiveness of these devices, the FDA has established a comprehensive set of regulations known as the Quality System Regulation (QSR), outlined in 21 CFR Part 820.
Compliance with 21 CFR Part 820 is essential for medical device manufacturers who intend to market their products in the US. The QSR covers all aspects of the design, manufacture, and distribution of medical devices.
Overview of 21 CFR Part 820
21 CFR Part 820 known as the FDA’s Quality System Regulation (QSR) for medical devices.
It establishes the minimum requirements for the design, manufacture, packaging, labeling, storage, installation, and servicing of medical devices.
The QSR applies to all medical device manufacturers who intend to market their products in the USA.
Compliance with this regulation is mandatory .
Failure can result in penalties, fines, product seizures, or criminal charges.
Subparts of 21 CFR 820
There are 15 subparts of 21 CFR 820. Each one focuses on a particular aspect of the medical device lifecycle. They are as follows:-
- Subpart A-General Provisions
- Subpart B – Quality System Requirements
- Subpart C – Design Controls
- Subpart D – Document Controls
- Subpart E – Purchasing Controls
- Subpart F – Identification and Traceability
- Subpart G – Production and Process Controls
- Subpart H – Acceptance Activities
- Subpart I – Nonconforming Product
- Subpart J – Corrective and Preventive Action
- Subpart K – Labeling and Packaging Control
- Subpart L – Handling, Storage, Distribution, and Installation
- Subpart M – Records
- Subpart N – Servicing
- Subpart O – Statistical Techniques
Requirements of 21 CFR Part 820
The QSR is a comprehensive regulation that covers all aspects of the design, manufacture, and distribution of medical devices. Some of the key requirements of the regulation include:
- Quality System Requirements Medical device manufacturers must establish and maintain a documented quality system for their specific device type, including procedures for design, manufacture, and distribution.
- Management Responsibility Management must establish, implement, and maintain the quality system, and appoint a designated management representative to oversee it.
- Design Controls Medical device manufacturers must establish and maintain design procedures, including risk analysis, design inputs, and design verification and validation.
- Document Controls Medical device manufacturers must establish and maintain document control procedures, including review and approval, changes, and retention.
- Purchasing Controls Medical device manufacturers must establish and maintain purchasing procedures, including supplier selection, evaluation, and monitoring.
- Production and Process Controls Medical device manufacturers must establish and maintain production and control procedures, including process validation, equipment calibration, and personnel training.
- Acceptance Activities Medical device manufacturers must establish and maintain acceptance procedures, including inspection, testing, and verification
- Labeling and Packaging Medical device manufacturers must establish and maintain labeling and packaging procedures, ensuring accurate and complete labeling and appropriate packaging for intended use.
- Device Distribution Medical device manufacturers must establish and maintain distribution procedures, ensuring proper packaging, labeling, shipping, and documentation.
Compliance Strategies to comply with the QSR
Medical Device manufacturers should consider the following strategies:
- Establish a Quality System Medical device manufacturers must implement a documented quality system appropriate for their device type, including design, manufacture, and distribution procedures
- Conduct Internal Audits Medical device manufacturers must conduct regular internal quality system audits by qualified, independent personnel to ensure QSR compliance. Findings must be documented and non-conformities promptly addressed.
- Provide Employee Training Medical device manufacturers must provide regular QSR training to employees on their specific roles and responsibilities to ensure compliance.
- Maintain Good Documentation Practices Medical device manufacturers must establish and maintain good documentation practices to ensure accurate, complete, and retrievable quality system records, including proper signatures, dates, and change procedures.
- Monitor Suppliers Medical device manufacturers must monitor suppliers to ensure QSR compliance, including supplier audits and documentation review to ensure component and material specifications are met.
- Respond to Complaints and Adverse Events Medical device manufacturers must establish and maintain complaint and adverse event handling procedures, including root cause investigation and corrective and preventive actions to prevent recurrence.
By following these strategies, medical device manufacturers can ensure that their devices are safe and effective for use by patients.
Medical device manufacturers must comply with the FDA’s QSR to ensure the safety and effectiveness of their products, avoid regulatory penalties, and stay informed of the latest regulatory changes. Complying with the QSR is essential for protecting patients and ensuring the public’s trust in medical devices.
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