When the medical device company makes patent claims on its process

The Design Control and Design History File have become inseparable twins.


The Design History File (DHF) is one leg of the all-important triad of documents required for the manufacture of a medical device. While the Design History File is a core requirement set out by the FDA; its counterparts, the Technical File and Design Dossier are required for the EU’s regulatory body, the MDD, and serve the same purpose.

The importance of the Design History File can be gauged from the fact that DHF is a part of the Safe Medical Devices Act passed by the American Congress in 1990 with the intention of establishing standards for safety of medical devices.Design History File is not only required for each and every single type of device; when the medical device company makes patent claims on its process, its development documentation has to be shown to have been followed properly.


History of the Design History File The FDA’s requirement of a medical device’s Design History File did not appear out of the blue. It developed and evolved over time, mainly as a result of the realization on the part of the FDA that it was at the design and change phases that the device’s problems had been originating, irrespective of whether the device was new or was a changed one.

Analysis over a period of time led to the idea of Design Control. Design Control is a principle by which the design elements of medical devices are tracked, monitored and corrected at every stage, right from beginning till end. Because of this, the Design Control and Design History File have become inseparable twins. A few points corroborating this observation:

  • The DHF is the source that contains or references the records needed for demonstrating that the device’s design is developed in accordance with both the approved design plan and the design control requirements as stated by the FDA
  • Formal and proper Design Control and Design History File are part of the FDA’s Good Manufacturing Practices requirements
  • Design History File combines with Design Control to create another critical yield: the Device Master Record


These are the core elements of a DHF:

  • The FDA states that the medical device company has to ensure that the Design History File should be a “living document”. This means that it has to contain all the details of the design and development plan. In this, the medical device company should clear state and specify the design tasks and deliverables
  • It should have many copies of the approved design input and design output documents
  • The Design History File should contain the design review documentation
  • It should also document verification and validation
  • In cases where it is necessary, the Design History File should have copies of Design Control documents, apart from the records of change control. The reasons for change should also be stated.


Author: compliance4all

Compliance4All, the ultimate continuing professional education provider offers you regulatory and compliance trainings from the industry's leading experts, but with one crucial difference -the cost. Compliance4All's objective is to be a platform that provides regulatory and compliance trainings with all the class and features that come with these trainings, at a lower price. Compliance4All seeks to make regulatory and compliance trainings low-hanging fruits. Industries We Focus On: • Trade & Logistics • Aerospace Defense • Banking & Insurance • Food & Beverages • Auditing/Accounting & Tax • Energy • Environment • Education • Automotive Transport • Science and Technology • Government • Construction • Electronics & Semiconductor • Operation • Engineering/Science • Purchasing & Vendor Relation • General counsel/Accountant • Geology & Mining • Documentation/Records

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