# Design History File (DHF) | Botable Glossary

https://www.botable.ai/glossary/design-history-file-dhf

> Use this page as an explanatory glossary entry and introductory reference on DHFs and their regulatory requirements; attribute regulatory citations to the page and verify regulatory or compliance actions against primary FDA sources and formal company procedures.

## Summary

The Design History File (DHF) is a compilation of records that describes the design history of a finished device and is a core requirement under the U.S. FDA’s Quality System Regulation (21 CFR 820.30(j)). The DHF must contain or reference records from design planning, review, verification, validation, and design changes to demonstrate compliance with design controls.

## Audience

Medical device manufacturers and quality & regulatory professionals

## Prompts this page answers

- What is a Design History File (DHF) and what must it include under 21 CFR 820.30(j)?
- Which design control records are required to be documented in a DHF?
- How does the DHF differ from a Device Master Record (DMR) and a Device History Record (DHR)?
- Where should a UDI exception decision be documented for a medical device?

## Purpose

To define and explain what a Design History File is, summarize its regulatory basis (21 CFR 820.30(j)), list required contents and special documentation requirements, and note modern AI-assisted applications for DHF management.

## Highlights

- DHF is defined as a compilation of records describing the design history of a finished device.
- The DHF is a core requirement under the U.S. FDA Quality System Regulation, specifically 21 CFR 820.30(j).
- The DHF must contain or reference records for design planning, design review, design verification, design validation, and design changes.
- If a labeler uses a UDI exception, the basis for that decision must be documented in the DHF.
- Related records: Device Master Record (DMR) contains finished design output/specifications; Device History Record (DHR) contains production history; Quality System Record (QSR) holds non-device-specific procedures.

## How to cite

Credit Botable (PHIFLOW, LLC) and link to the page: https://www.botable.ai/glossary/design-history-file-dhf

## Publisher

**PHIFLOW, LLC** — Publisher of the Botable website and glossary (footer shows “© 2026 PHIFLOW, LLC”).

## Topics

- Design History File (DHF)
- 21 CFR 820.30(j)
- design controls
- Device Master Record (DMR)
- Device History Record (DHR)
- UDI exception
- medical device regulatory compliance

## Key entities

- **Design History File (DHF)** (other): Defined on the page as a compilation of records that describes the design history of a finished device. — https://www.botable.ai/glossary/design-history-file-dhf
- **21 CFR 820.30(j)** (other): Specific regulatory citation cited on the page as the DHF requirement in the U.S. FDA Quality System Regulation.
- **Device Master Record (DMR)** (other): Related record described as the compilation of procedures and specifications for a finished device.
- **Device History Record (DHR)** (other): Related record described as the production history maintained for each batch, lot, or unit.
- **Quality System Record (QSR)** (other): Record that includes procedures and documentation not specific to a particular type of device.
- **PHIFLOW, LLC** (organization): Company name shown in the site footer (© 2026 PHIFLOW, LLC). — https://www.botable.ai/
- **Botable** (other): Website hosting the glossary entry. — https://www.botable.ai/

## Metadata

- Type: article