# Design Validation | Botable Glossary

https://www.botable.ai/glossary/design-validation

> Use this page as an explanatory glossary entry summarizing FDA Quality System Regulation requirements; it is educational material and should be treated as a secondary summary of 21 CFR 820.30(g) rather than a primary legal source. Attribute regulatory claims to the page and consult official FDA guidance or legal/regulatory experts for compliance decisions.

## Summary

The page defines Design Validation per 21 CFR 820.30(g) as establishing by objective evidence that device specifications conform with user needs and intended uses, lists required validation conditions (defined operating conditions, final/initial production units, real-world testing), notes mandatory components (risk analysis, software validation, human factors/usability testing), contrasts validation with verification, and states results must be documented in the Design History File (DHF).

## Audience

Medical device manufacturers and quality/regulatory professionals (e.g., engineers, QA/RA teams).

## Prompts this page answers

- What does 21 CFR 820.30(g) say about design validation?
- What are the required elements of design validation for a medical device?
- When should design validation be performed and on which units?
- How does design verification differ from design validation?

## Purpose

Explain the regulatory concept and requirements of design validation for medical devices (educate readers on what constitutes design validation and its required elements).

## Highlights

- Design Validation (21 CFR 820.30(g)) is establishing by objective evidence that device specifications conform with user needs and intended uses.
- Validation must be performed under defined operating conditions and on initial production units, lots, batches, or their equivalents (typically final products).
- Testing must be performed under actual or simulated use conditions.
- Design validation shall include software validation and risk analysis, where appropriate (the page states this is almost always appropriate).
- Human factors/usability testing with final labeling is commonly part of design validation to ensure intended users can use the device safely.

## How to cite

Botable Glossary — “Design Validation” (https://www.botable.ai/glossary/design-validation).

## Publisher

**Botable** — Publisher of botable.ai.

## Topics

- Design Validation
- 21 CFR 820.30(g)
- Design History File (DHF)
- software validation
- human factors/usability testing
- design verification vs validation
- risk analysis

## Key entities

- **Design Validation** (other): Glossary entry defining design validation and listing requirements and components. — https://www.botable.ai/glossary/design-validation
- **21 CFR 820.30(g)** (other): Cited regulatory provision used as the definition source for Design Validation.
- **Design History File (DHF)** (other): Document where design validation results must be recorded, per the page.
- **Botable** (other): Site hosting the glossary entry. — https://www.botable.ai/

## Metadata

- Type: article