Design Validation

‍Design Validation (21 CFR 820.30(g)) is the final and most important step in the design control process. It confirms that the completed device design works correctly for the people who will actually use it.

In the simplest terms, Design Validation answers the ultimate question: "Did I make the correct product?".

Design Validation (21 CFR 820.30(g))

Design Validation means establishing by objective evidence that device specifications conform with user needs and intended use(s).

Its primary goals are to ensure:

• User Needs are Met: The final device design conforms to defined user needs and intended uses. This means the product is effective and safe when used by the patient or clinician, fulfilling its original purpose.
• Safety and Effectiveness: Validation activities are intended to assure that finished devices will be safe and effective.

Key Requirements for Validation Procedures

Manufacturers must establish and maintain procedures for validating the device design. These procedures require validation to be performed:

1. Under Defined Conditions: Testing must be performed under defined operating conditions.
2. On Final Products: Validation is performed on initial production units, lots, or batches, or their equivalents. It is typically performed on the final product.
3. Real-World Testing: Testing must be performed under actual or simulated use conditions.

Mandatory Components of Validation

Design validation must include several elements to ensure comprehensive safety and usability:

• Risk Analysis: Design validation shall include software validation and risk analysis, where appropriate. Because the FDA states that "where appropriate" means it is appropriate unless documented otherwise, it is almost always appropriate to perform risk analysis. Risk analysis helps ensure that any changes made during the design process do not introduce new hazards.
• Software Validation: If the device incorporates software, validation activities must include software validation.
• Human Factors/Usability Testing: The goal is to improve the design of devices to minimize potential use errors and resulting harm. Design validation often includes human factors/usability validation testing with the final version of the labeling to mitigate the risk of failure to correctly operate the instrument. For example, studies must demonstrate that the intended user can use the device safely.

Distinction from Design Verification

Validation is often confused with Verification, but they address fundamentally different questions:

The results of the design validation must be documented in the Design History File (DHF).

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