Design Controls – Medical Device GMP

Title 21 of the Code of Federal Regulations (CFR) contains regulations pertaining to various aspects of food and drugs in the United States. Subpart C of 21 CFR 820 specifically deals with "Design Controls" for medical devices. These regulations are enforced by the Food and Drug Administration (FDA) to ensure that manufacturers of medical devices establish and follow comprehensive design control processes to develop safe and effective medical devices.

Here are some key elements and requirements outlined in 21 CFR 820 Subpart C - Design Controls:

  • Design and Development Planning: Manufacturers must establish and maintain procedures for planning the design and development of their medical devices. This includes defining objectives, design inputs, and a project plan.

  • Design Inputs: Manufacturers must document the design inputs, which include requirements and specifications for the medical device. These inputs should be clear, complete, and traceable.

  • Design Outputs: Design outputs are the results of the design process, including drawings, specifications, and other documents that define the device. Manufacturers must ensure that design outputs meet design input requirements.

  • Design Review: Manufacturers are required to conduct formal design reviews at various stages of the design process to ensure that the design meets the defined requirements.

  • Design Verification: Verification involves testing and other activities to confirm that the device meets its design specifications. Manufacturers must establish procedures for design verification.

  • Design Validation: Validation ensures that the device meets user needs and intended uses under actual conditions of use. Manufacturers must conduct design validation before commercial distribution.

  • Design Transfer: Procedures should be in place to ensure that the design is correctly transferred to production and that any necessary documentation is provided to manufacturing.

  • Design Changes: Changes to the design must be controlled through established procedures. Manufacturers should evaluate the impact of design changes on the device's safety and effectiveness.

  • Design History File (DHF): Manufacturers must maintain a DHF for each medical device. The DHF includes records of the design process, design reviews, and design verification and validation activities.

  • Device Master Record (DMR): A DMR contains all the specifications and documentation necessary to manufacture a medical device. Manufacturers must establish and maintain DMRs for each device.

  • Design Reviews: Manufacturers must conduct formal design reviews at different stages of the design process to evaluate the progress and make necessary adjustments.

  • Design Validation: Validation is conducted to ensure that the device performs as intended under actual conditions of use.

  • Design Transfer: Procedures must be in place to ensure that the design is accurately transferred from the design phase to the production phase.

  • Records Retention: Records related to design controls, including design inputs, outputs, reviews, and verification/validation activities, must be retained for a specified period, typically at least one year after device life-time.

These requirements in Subpart C are crucial to ensuring that medical devices are designed and developed with a strong focus on safety, efficacy, and quality. Compliance with these regulations is essential for medical device manufacturers to obtain FDA approval and ensure the safety and effectiveness of their products.

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