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FDA Design Control

FDA Design Control and Design Control Process

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CQ Enterprise Quality Management System

Introduction to FDA Design Control

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What is FDA Design Control?

Design controls are defined as an interrelated set of practices and procedures incorporated into the design and development process. FDA design controls make a systematic assessment of the design an integral part of development. With design control, any deficiencies in design input requirements or discrepancies between the proposed designs and requirements are detected early and corrected immediately in the development process. Design controls intend to increase the chances of transferring the design to production, without much difference, into a device suited for its intended use.

FDA Design Control

How does FDA Design Control work?

Design controls for medical devices demonstrate the safety, effectiveness, and usage indication. The FDA design control guidance applies to

  • OSHA -1
    The design of medical devices and their associated manufacturing processes
  • OSHA -2
    New designs, improvements, and modifications to an existing device

The FDA design control guidance discusses subjects in which they appear in the FDA’s Quality System Regulation. It is cross-referenced to International Organization for Standards (ISO) 9001:1994, Quality Systems Model for Quality Assurance in Design, Development, Production, Installation, and Servicing, and the ISO draft international standard ISO/DIS 13485, Quality Systems Medical Devices Particular Requirements for the Application of ISO 9001, dated April 1996.

How does the FDA Design Control process improve production?

FDA design controls provide managers and designers with improved visibility of the design process. With improved visibility, managers can direct the design process more effectively by recognizing problems earlier, making the necessary corrections, and modifying resource allocations. Designers benefit from the design control process as there is an enhanced understanding of the degree of conformance of a design to the user and patient needs, leading to improved communications and coordination among all participants in the process. The design and development planning is based on section 820.30(b) of the FDA guidance. The guidance requires:

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    Every manufacturer to establish and maintain plans describing the design and development activities. The manufacturer must also define all responsibilities for implementation.
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    The plans to be used to identify and describe the interfaces with different activities or groups involved in the design and development process.
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    The plans to be consistently reviewed, updated based on inputs, and approved as design and development evolves.

What are the various clauses in the FDA design control process?

FDA 21 CFR 820.30 defines the various FDA clauses as part of FDA design control. They are

  • ISO 9001
    A basic procedure of the design control process is drafted using questions focusing on process definition, implementation, and documentation.
  • ISO 9001
    Design and development planning
    During the planning stage, various aspects such as logistical coordination, clearly defined responsibilities of team members and contractors are finalized. This stage also defines the timeline which sets the project pace, teams to be hired, and any future activities that need planning.
  • ISO 9001
    Design input
    Design inputs focus on three requirements namely functional, performance, and interface. Design input is an important part of Subpart C of the QSR that defines all product and market specifications, including the needs of the market, and the consequent effects of each aspect of the product.
  • ISO 9001
    Design output
    Design output should act as a manuscript listing all the components used in medical devices. It is a document that will be given to manufacture the device and its necessary components. When compared to the design input, design output must be tested for conformity. Design output should include all physical and numerical design aspects and must be recorded in the Device Master Record.
  • ISO 9001
    Design review
    Design reviews are conducted at strategic points during the design process. Design review is aimed at keeping the project focus, share feedback on the designer on potential issues, and act as a checkpoint before moving to other project aspects such as materials, software, techniques for construction, electronics, pneumatics. The results of a design review is stored documented in the form of a design history file (DHF) that includes details such as design identification, date, and name of the individual conducting the review.
  • ISO 9001
    Design verifications
    Design verification gives designers the freedom to showcase and prove that the device meets the exact product specifications. This stage continues through the development process as various components are tested to confirm that the device is built as planned. Design verification focuses primarily on the product specification while validation is about market specifications such as user needs, guidance documents, standards, among others.
  • ISO 9001
    Design validation
    Design validation focuses on the market specification to confirm it has been met. To do so, the product is put to test in the expected or stimulated environment to understand the performance. There are two kinds of validation, namely process, and design validation. Once validation is completed and the product becomes ready for production, the manufacturer must create a plan to execute proper mass manufacturing. This next step is called design transfer.
  • ISO 9001
    Design transfer
    Once the device is ready for production, proper instructions must be given to ensure the device is produced by following all the instructions acquired through documentation, training, and computer programs. To avoid mishaps, all instructions should be clear and thorough so that any unforeseen change in personnel or machinery can be dealt with using the instructions.
  • ISO 9001

    Design changes
    Design changes must be controlled through two different components: document control and change control.

    • Document control insists that all document updates which include files, pictures, or any design are thoroughly checked for the latest updates
    • Change control focuses on the number of mistakes and corrections that were recorded due to any review or verification
  • ISO 9001
    Design history file
    The design history file is the pinnacle of design controls. It is a formal document prepared for every medical device to include all the required documents from early stages of production. It is an organised account of the product’s manufacturing process. The main purpose of the file is to showcase that the team followed the design plan and all of the requirements were fulfilled.

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What is the Design Control process guidance?

While using design control process guidance, manufacturers must focus two aspects –

  • The time and effort needed to develop and incorporate the controls into the design process
  • The intrinsic value of design controls

As design control focuses on correcting design errors early in the design and development process, organizations must focus on having a written design control system to understand the requirements while also having a baseline to review the system to periodically review for improvements based on problems, history, and previous failures of the system. Before setting up the design control process guidance, three important definitions must be clearly understood.

  • Management with executive responsibility
  • Quality
  • Quality system

Once the definition is clear, follow the design control process guidance as discussed below.

Design Control Process

  • ISO 9001
    Clearly define user needs specifying how the device is expected to meet their requirements
  • ISO 9001
    Design and develop a plan that details the team’s efforts to handle design control during the development process
  • ISO 9001
    Describe the design inputs that describe the specifications of the product based on user needs
  • ISO 9001
    Document the design outputs, specifically design, materials, and components needed to build medical devices in the form of drawings and diagrams
  • ISO 9001
    Conduct and sign off design review that helps evaluate design requirements at various stages of development
  • ISO 9001
    Test the product as part of design verification to prove that the device works as intended
  • ISO 9001
    Perform a design validation test to check if the device meets the user needs as defined earlier
  • ISO 9001
    Focus on design transfer or design production with the actual process of producing a medical device
  • ISO 9001
    Applicable to the entire lifespan of a medical device, the design change is about revisions that may be needed to the product

Frequently Asked Questions

Benefits of establishing FDA design control process in an organization
  • Helps employees understand the requirements, process, and expectations of design
  • Assures the quality of design
  • Acts as a baseline to review the system periodically for further improvements
  • Improves the chances of a design approved for production translating into a device relevant for its intended use
  • Improves design process visibility
What are the components of the quality system for medical device product developments?
What are the features of CQ’s Document Management Solution?

CQ Document Management helps manage the entire document lifecycle, gain complete visibility and rely on a single source of truth across all locations for more effective decision making.

  • Boost productivity and efficiency with a workflow-driven process that streamlines the entire document review/approval process easily, on a consistent and timely basis
  • Manage all the documents in your workflows, while integrating with other quality processes critical to regulatory compliance, such as registration and surveillance audits, CAPA escalations, non-conformance, change control, and customer complaints
  • Eliminate separate legacy document silos with a single enterprise-wide system to improve collaboration
  • With easily accessible documents and workflow capabilities tightly coupled with CQ’s Training functionality, ensure employees are notified when CAPA-driven processes or work instructions change, and effortlessly track that all appropriate reviews have occurred
  • Always have access to the most recent set of approved procedures and Best practices that can be easily shared and standardized across the organization

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