How to you create a Design History File (DHF)?

This webinar explains best practices for generating a design history file (DHF) for compliance with 21 CFR 820.30j and ISO 13485:2016, Clause 7.3.10.

21 CFR 820.30(j) - Design history file. Each manufacturer shall establish and maintain a DHF for each type of device. The DHF shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part.

This presentation includes specific documentation updates to comply with ISO 13485:2016 that was released on March 1, 2016 and how to integrate your design process with preparation of regulatory submissions such as a 510k or CE Marking submission.

Design History File (DHF) for 21 CFR 820.30j compliance
The most frequent category of FDA Form 483 inspection observation is design controls (i.e., 21 CFR 820.30). There are 10 different sections of the design controls requirement. Manufacturers that do not have design controls in place will frequently receive multiple observation findings during the same inspection–all related to design controls. The most common design control observations are:

1. A procedure for design and development has not been established in accordance with 21 CFR 820.30a
2. A procedure for design transfer has not been established in accordance with 21 CFR 820.30h
3. A procedure for design changes has not been established in accordance with 21 CFR 820.30i
4. A design history file (DHF) has not been established in accordance with 21 CFR 820.30j

If a manufacturer has no procedure for design controls, then the manufacturer could receive 4 different observations on FDA Form 483.

ISO 13485:2016 Requirements for Design Files
On March 1, 2016 the 2016 version of ISO 13485 was released. The new version of the Standard now requires procedures for design transfer, design changes and design and development files in an effort to be harmonized further with US regulatory requirements. Therefore, this presentation was created to specifically identify changes needed to your design controls procedure in order to comply with the latest version of the Standard.