Understand Quality Systems Regulations to Avoid FDA Enforcement Actions

quality systems regulations

Quality Systems Regulations ButtonMedical devices are regulated in the United States by the Food and Drug Administration (FDA) because of the great responsibility and risk they carry regarding human life. To be sold in the U.S., a medical device must effectively diagnose and treat the condition it is supposed to and be safe for its users. If it doesn’t, it is subject to enforcement actions by the FDA, which could mean big consequences for your business and patients. To avoid these actions, it is imperative for medical device companies to understand and adhere to quality systems regulations (QSR).

Quality system regulation for medical devices as outlined by the FDA require manufacturers to establish and follow quality systems during medical device development to help ensure their products consistently meet requirements and specifications. These quality systems are also known as current good manufacturing practices (CGMPs).

The FDA provides information outlining their expectations for quality systems regulations in its Code of Regulations Title 21 Part 820. Because it regulates so many different types of devices, FDA QSR compliance code does not detail how a manufacturer must produce a specific device, but instead provides a framework for manufacturers to follow through developing and following procedures and producing in a way that is appropriate and according to current state-of-the-art manufacturing for that device. Understanding and applying the regulations can be tricky, and even excellent quality systems can experience unforeseen challenges or gaps in their design or implementation. When that happens, it draws the attention of the FDA, but also offers the opportunity to improve.

How often does the FDA inspect medical device manufacturers? Since it regulates using a risk-based approach, the FDA also inspects using a risk-based approach. If the FDA learns of problems or receives complaints about a product, it will prioritize inspecting that manufacturer. This means it is even more critical to ensure you are compliant with quality systems regulations for a favorable inspection outcome.

A key component of quality systems regulations relates to Design Controls. The FDA requires all Class II (medium risk) and Class III (high risk) devices adhere to Design Control regulations. FDA Design Control guidance outlines a formalized approach to the development of medical devices and requires many layers of documented proof that show the FDA exactly how you have planned for and ensured the safety and efficacy of your device. It requires several components be incorporated in the creation of your product, including design and development planning, design inputs, design outputs, design review, design verification, design validation, design transfer, design changes, and design history file (DHF). It also requires they design quality systems, conduct documented quality audits, perform corrective actions, and document those corrective actions.

Another component is the FDA’s Part 820.180, which outlines that quality systems regulations adherence must be documented and that those records must be legible and readily available for review and copying by FDA employee(s) in the event of an inspection. The FDA also expects the manufacturer to be able to defend their methods and procedures as being “appropriate and adequate.”

Simply put, to avoid enforcement actions by the FDA, it is critical to have a comprehensive understanding of quality systems regulations, and to make sure your quality systems are strong, practiced, reviewed regularly, and thoroughly documented. In addition, quality systems regulations are not only important for the health and safety of those using your device, but also for efficient FDA approval of your device – the FDA must see quality systems in place as part of their approval pathways including de-novo premarket review for low and moderate risk devices, the 510(k) process for a new device improving on an existing device or process, or the premarket approval pathway for high-risk devices and/or brand-new technology that has never been done before.At Sterling, we are experts at navigating FDA compliance processes, providing clients guidance through the complexities to achieve a successful medical device that sets the bar for high quality in the industry. If we can help you understand quality systems regulations or guide you in using robust medical device quality systems, please contact us today.


Carrie Britton
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