Design History File (DHF) SOP

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Design History File (DHF) SOP

This Standard Operating Procedure (SOP) is ready to use and meets expectations of 21 CFR 820 for establishing a structured Design History File (DHF). The 8-page SOP only needs some minor modification before it can be used as the backbone of the documentation needed during design control.


FDA defines the Design history file (DHF) as a compilation of records which describes the design history of a finished device [820.3(e)]. Therefore the DHF covers the design activities used to develop the device, accessories, major components, labeling, packaging and production processes. As mentioned in 820.30(j) it is required that each manufacturer shall establish and maintain a DHF for each type of device.


Regulatory basis, reference documents 

21 CFR Part 820 - Quality System Regulation, Subpart C - Design Controls, 820.30 Design controls

ISO 13485:2016: Medical Devices - Quality management systems ¬Requirements for regulatory purposes

FDA/CDRH - Design Control Guidance for Medical Device Manufacturers, March 11, 1997



Table of Content:

1     Purpose

2     Objective

3     Regulatory basis, reference documents

4     Responsibility and accountability

4.1       Design Review Committee

4.2       Quality Assurance

4.3       Project Leader (PL) / Head of Engineering (HE)

4.4       Function / Area Leaders

5     Related documents

6     Definitions

7     Procedure

7.1       General Maintenance of Design History File

7.2       Content of the DHF

7.3       Day to day DHF work

7.4       Numbering of the Design History File

7.5       Security of Design History File Information

8     Attachments

9     SOP distribution

10         Health, safety and environmental considerations


Size and Format:

  • Microsoft Office 2003
  • Word File
  • 8 pages procedure

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