The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published detailed guidance dedicated to design control.

The document was issued by the Center for Devices and Radiological Health (CDRH) earlier in 1997. The guidance is based on the provisions of regulation 21 CFR 820.30 and provides additional clarifications to be considered by the medical device manufacturers.

The scope of the document covers the revised Current Good Manufacturing Practice (CGMP) regulations contained by the Quality System Regulation 21 CFR Part 820. However, the aforementioned regulation does not provide strict requirements but outlines the general framework since the applicable approach should be flexible enough due to differences in medical devices subject to review. In particular, the authority states that controls employed by the manufacturer should correspond to the design of the device, provided they are compliant with the applicable regulatory requirements. The authority encourages the medical device manufacturers and other parties involved to provide their feedback and suggestions – they will be considered in the course of future improvement.

Regulatory Background

The present guidance is intended to assist responsible persons in interpreting the current regulatory requirements. As stated by the authority, the approach described therein is based mostly on principles to be applied rather than the particular requirements. The Agency clarifies the concepts behind the regulatory requirements and provides practical recommendations regarding the way they could be implemented in particular cases.

Under the general rule, design controls should be incorporated in design and development processes in order to ensure that any discrepancies and deficiencies would be identified and repealed in a timely manner. By applying design controls, the manufacturer can make sure the design used for actual production would result in a device that will be fully compliant with the applicable regulatory requirements and meet its intended purpose. Design controls also facilitate the incorporation of necessary changes during the early stages of the design development process. Due to the large variety of designs of medical devices, design controls should vary accordingly. The aim of the present guidance is to describe the way the general regulatory requirements could be applied in particular cases. The authority additionally emphasizes that the manufacturer should not merely implement the most time- and effort-effective approach but establish a proper balance with regard to the intrinsic value of design controls. It is stated that the earlier deficiencies are identified, the fewer resources are needed to make necessary improvements and corrections.

The scope of the guidance covers the design of medical devices and also the design of manufacturing processes related thereto. The principles described in the guidance could be applied for the development of both new devices from scratch and modifications to existing devices. The authority additionally emphasizes that design controls should be applied within the whole lifecycle of the medical device, from the initial design development to changes and modifications made to the device after it is placed on the market, including corrective actions taken by the manufacturer in response to failures and malfunctions of the device in order to mitigate the risks associated thereto.

The FDA states that the particular design control examples provided are intended exclusively to assist medical device manufacturers in applying the underlying principles and should not be construed as the only acceptable ways of action in particular situations. There could be alternative approaches that will be more suitable due to the specifics of the device in question and the needs of patients. The manufacturer has certain flexibility in applying general principles described herein, provided that the approach applied complies with the regulatory requirements.

Application of Design Controls 

As mentioned, design controls could be applied with regard to any device development process. 

The Agency provides a chart describing the general approach to design controls and design process in general (the chart was initially created by the Medical Devices Bureau, Health Canada). According to the chart, the whole process includes several consecutive steps in a logical sequence. The authority also emphasizes the importance of feedback to be received at each stage. Each step should include verification in order to ensure compliance with the patients’ needs and also with the applicable regulatory requirements. In particular, the Agency states that each design input is converted into a new design output; each output is verified as conforming to its input; it then becomes the design input for another step in the design process. The authority also states that an important role should be played by reviews to be conducted at each step of the design development process. According to the document, in the course of this process, a single requirement is transformed into a set of requirements and reflected in the specifications, while several verifications take place in order to ensure these requirements are met. 

Concurrent Engineering 

The approach described above could be applied “as is” only for simple medical devices. Since most cases are more complex, the approach must be modified accordingly. In such cases, a concurrent engineering model should be applied to the design processes. According to the concurrent engineering approach, production and service specialists are involved within the whole design development process from its very beginning. This not only to reduces the overall manufacturing costs but also improves the quality of the product in general. This approach covers a set of practices and techniques. The Agency states that concurrent engineering may blur the line between development and production. From one side, it moves the focus on the development of production processes from the manufacturing stage to design. At the same time, certain elements of design could be applied in production before being approved. Hence, such an approach is far more complex but also offers additional advantages and opportunities for improvement. 

Risk Management and Design Controls

According to the present FDA guidance, risk management is the systematic application of management policies, procedures, and practices to the tasks of identifying, analyzing, controlling, and monitoring risks, and is intended to be a framework within which experience, insight, and judgment are applied to successfully manage risk. The Agency pays special attention to risk management due to its important role and the effect it causes on the development process in general.

It is stated that proper risk management should be applied at all the stages of the product lifecycle, starting from the initial development of requirements. The main purpose of the risk management process is to identify and mitigate risks in a timely and proper manner. As mentioned, it is easier to introduce necessary changes at the early stages of the design development process rather than when it has already been transferred to production.

In summary, the present FDA guidance describes the general principles related to design controls and the way they should be applied in particular situations. The document provides an overview of the current regulatory approach and provides medical device manufacturers with additional recommendations to be considered.


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