Design Changes

Design Changes (21 CFR 820.30(i)) is a crucial part of the FDA's Quality System Regulation (QSR) for medical devices, specifically focusing on how manufacturers must control alterations to a device design once it is established.

The regulation, 21 CFR 820.30(i) Design changes, defines the strict procedures manufacturers must follow to manage any alterations to their device design.

The regulation mandates that manufacturers must "establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation".

This requirement ensures that quality, safety, and effectiveness are built into the medical device from the start and maintained through any lifecycle modifications.

Principles of Design Change Control

The procedure for implementing design changes or modifications, as outlined in the FDA's Design Controls requirements, involves several key principles that must be satisfied before the change can take effect:

1. Identification and Documentation

Manufacturers must have documented procedures for the identification and documentation of all design changes and modifications.

• Records of changes must be maintained.
• Change records must include a description of the change, identification of the affected documents, the signature of the approving individual(s), the approval date, and when the change becomes effective.
• This documentation should be cataloged to meet the requirement for identification.
• The organization must retain documented information on design and development changes.

2. Review and Approval

Design changes and modifications "shall be identified, documented, reviewed and approved by authorized personnel before their implementation".

• The review and approval process must be defined, typically performed by authorized personnel.
• Changes to documents established for quality requirements are typically reviewed and approved by individuals in the same function or organization that performed the original review and approval, unless otherwise specifically designated.
• The decision to approve or reject a change request must be documented, and if rejected, the reasons must be supplied to the initiator.

3. Verification or Validation (Testing the Change)

Before implementation, the design change must undergo validation or, where appropriate, verification. This is a critical principle to ensure the change does not compromise the device's original integrity.

• Design Verification confirms that the revised design output meets the design input requirements (e.g., "I made the product correctly" based on the new specifications).
• Design Validation establishes objective evidence that the revised specifications conform with user needs and intended use(s) (e.g., "I made the correct product" after the change).
• If a design modification is made, verification or validation must be repeated.
• The results of verification or validation activities for production or process changes must be documented.

4. Integration with Design History File (DHF)

The results of the design changes process are collected in the Design History File (DHF), which is the compilation of records describing the design history of the finished device. The DHF must contain or reference records demonstrating that the design was developed, and subsequently changed, in accordance with the approved design plan and Quality System requirements.

Context in the Medical Device Industry

The rigorous control of design changes is essential because they represent a continual role of Design Controls throughout the premarket and postmarket phases of device development.

• Preventing Future Issues: Adequate design controls, including proper change management, are recognized as a way to improve and prevent future quality issues. Historically, inadequate design controls may have prevented a significant percentage of voluntary recalls.
• Risk Management: Design changes should be managed within the scope of risk management. Design validation, in particular, should include risk analysis where appropriate. Manufacturers must document how risk control measures are implemented to address device system hazards when design changes are made.
• Premarket Notifications (510(k)): For devices requiring premarket notification (510(k)), a new notification may be required if the device is about to be significantly changed or modified in design, components, method of manufacture, or intended use. A change or modification that could significantly affect the safety or effectiveness of the device (e.g., a significant change in design, material, composition, energy source, or manufacturing process) requires a premarket notification.
• PMA Supplements: For devices with approved Premarket Approval Applications (PMA), a PMA supplement must be submitted to the FDA for review and approval before making any change that affects the safety or effectiveness of the device. Changes requiring a supplement include alterations to performance or design specifications, components, or principles of operation that affect safety or effectiveness.
• QMSR Alignment (Future State): The FDA's new Quality Management System Regulation (QMSR, effective February 2, 2026) incorporates ISO 13485:2016 by reference. ISO 13485 requires control of design and development changes (Clause 7.3.9), and states that the outcomes of risk management are essential inputs for design and development. The focus on change management ensures that devices in production remain in conformity, especially concerning changes to the design or harmonized standards.

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