Medical Device Design Control: Design History File

As stated in § 820.3(e), "Design history file (DHF) means a compilation of records which describes the design history of a finished device."

The DHF covers the design activities used to develop the device, accessories, major components, labeling, packaging and production processes.

Requirements: § 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.

A Design History File (DHF) is a requirement of QSR 21 CFR Part 820. It is a certainty that in an audit from a regulatory body, information from the DHF will need to be provided. Manufacturer's would be well prepared for audits by regulatory agencies if they know the strengths and weaknesses of their DHF, and remediate as needed, prior to the agency showing up at their doorstep. Virtually every section of the design control requirements specifies information which should be found in the DHF. Manufacturer's need to be aware of what gaps exists between the actual DHF and the FDA's expectation.

There are no requirements on the location or organization of the design history file. In some cases, especially for simple designs, the designer will assemble and maintain the entire design history file. For larger projects, a document control system will likely be established for design documents, and these files will likely be maintained in some central location, usually within the product development department. The basic design information that may be maintained in a single project file in a specified location include:

• Detailed design and development plan specifying design tasks and deliverables.
• Copies of approved design input documents and design output documents.
• Documentation of design reviews.
• Validation documentation.
• When applicable, copies of controlled design documents and change control records.

The documents and records that are to be established and maintained within a DHF include:

Design Documents/Records	21CFR820	ISO 13485:2016
Design and Development Planning	820.30(c)	7.3.2
Design and Development Inputs	820.30(d)	7.3.3
Design and Development Outputs	820.30(e)	7.3.4
Design and Development Review	820.30(f)	7.3.5
Design and Development Verification	820.30(g)	7.3.6
Design and Development Validation	820.30(h)	7.3.7
Design and Development Transfer	820.30(i)	7.3.8
Design and Development Changes	820.30(j)	7.3.9

Source:

www.fda.gov

Related Training:

Creating a Good Design History File (DHF) for Audit Success
Design History Files and Technical Files under US FDA and EU MDD