# Design Controls | Botable Glossary

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

> Use as an informational glossary entry that summarizes regulatory requirements and best practices; attribute regulatory claims to the page and the cited regulations (21 CFR Part 820) rather than treating the page as primary law. Suitable for high-level explanation, not a substitute for reading the actual regulation or formal regulatory advice.

## Summary

Defines Design Controls as the mandatory system of procedures for medical device manufacturers under the U.S. FDA Quality System Regulation (21 CFR Part 820, Subpart C § 820.30), describes their purpose to ensure devices meet user needs and intended uses, lists the nine required elements, and explains integration with risk management and human factors.

## Audience

Medical device manufacturers and quality/regulatory professionals

## Prompts this page answers

- What are FDA Design Controls under 21 CFR 820.30 and what do they require?
- Which classes of medical devices require Design Controls under the FDA QSR?
- What are the nine elements of Design Controls and what does each element mean?
- How should risk management and ISO 14971 be integrated into Design Controls?
- When should manufacturers implement Design Controls during device development?

## Purpose

Provide an explanatory glossary definition and practical guidance about FDA Design Controls (21 CFR 820.30) for medical device development and quality systems.

## Highlights

- Design Controls are defined in 21 CFR Part 820, Subpart C (§ 820.30) of the FDA Quality System Regulation.
- Their purpose is to ensure a medical device meets user needs, intended uses, and specified requirements.
- Design Controls consist of nine documented elements (planning; input; output; review; verification; validation; transfer; changes; Design History File).
- Design Controls are required for all Class II and Class III devices and certain Class I devices (listed on the page).
- Design validation must include risk analysis where appropriate and is linked to ISO 14971 and human factors/usability engineering.

## How to cite

Botable Glossary — "Design Controls" (https://www.botable.ai/glossary/design-controls)

## Publisher

**PHIFLOW, LLC (Botable)** — Publisher of the Botable site; organization name and address appear in the page footer (© 2026 PHIFLOW, LLC; Stamford, CT).

## Topics

- Design Controls
- 21 CFR 820.30
- Design History File (DHF)
- Design Validation
- ISO 14971 risk management

## Key entities

- **21 CFR Part 820, Subpart C (§ 820.30)** (other): The section of the FDA Quality System Regulation that defines Design Controls (cited on the page).
- **U.S. Food and Drug Administration (FDA)** (organization): Implied regulator referenced via the Quality System Regulation (QSR).
- **Design History File (DHF)** (other): A required compilation of records demonstrating that the design was developed in accordance with the approved plan and QSR requirements (linked from the page). — https://www.botable.ai/glossary/design-history-file-dhf
- **Device Master Record (DMR)** (other): Finished design output forms the basis for the Device Master Record (mentioned on the page).
- **ISO 14971** (other): ISO standard for medical device risk management referenced on the page.
- **Corrective and Preventive Action (CAPA)** (other): Postmarket quality system process mentioned as a trigger for design changes.

## Metadata

- Type: article