As part of the Safe Medical Device Act in 1990, the FDA mandated the Design History File (DHF), which contains all the development documentation pertaining to a medical device/product/diagnostic, which is generated by the design control process. Preparing a DHF as per the Regulatory requirements and withstanding the Regulatory Agencies’ scrutiny is a key challenge for all the medical devices manufactures and developers.  

However, as long as the respective Regulatory demands are met while preparing the DHF, the documentation processes are seldom scrutinized for efficiency improvements. The best way to get through this is to establish and maintain a DHF that demonstrates the design developed in accordance with a particular Regulatory Agency’s approved design plan and the requirements. But, how should we go about compiling a DHF? What should it contain and what are the common pitfalls to avoid? Let’s look into them.

Common Challenges:  While trying to put together a DHF, organizations often face the below-mentioned challenges.

  • Paper Formats: Not surprisingly, paper is the common format of a DHF for many companies. Due to voluminous paper files all over, finding the appropriate content for a DHF, missing information or incomplete paperwork may occur as hurdles. And, most importantly, one may come across missing signatures or incomplete vital sections, which hinder the approvals. Kindly note that DHFs must be accurate and updated.
  • Disorganized Filing: Misfiled and mislead documents cause a big challenge and it can happen, when filing structures are spread across multiple platforms and the naming conventions are not consistent throughout the process. When documents are disorganized, companies find it hard to gather the apt information during audits and inspections, which leads to product recalls.
  • Overloading DHF: In the name of safety and efficacy, companies often tend to add everything possible to the DHF, like, cost studies or competitor analysis, which are not necessary. These aspects don’t relate to safety and efficacy and neither they meet the end-user’s needs. On a real note, a DHF should fit within a project file and must have information on design control activities.

What Should a DHF Contain?

A DHF is inclusive of all the documentation, which is created during the product development phase of a medical device. As a thumb-rule, DHFs must be accurate and consistently updated, even beyond the development phase and should contain detailed design and development plans, specifying the design tasks and deliverables for the device. Below listed are the important steps of the design control process and the list of documents that should be included in each step.

  • Design and development planning – The developed design plan document should be included
  • Design input – Include procedures for establishing design input that addresses the intended use and user needs and the copies of approved design input documents
  • Design output - Include procedure for defining and documenting design output design and the copies of approved design output documents
  • Design reviews – Include documents covering the design reviews
  • Design verification – Include documentation describing the design validation process and the approved results of the design validation
  • Design validation – Include the specific procedure and testing conditions used for design validation and the approved results of the design validation process
  • Design transfer - Include the documented product specifications that are developed and a description of the process used
  • Design changes - Include the documented design change process and documentation pertaining to any design changes that have taken place

On an end note, it is all about keeping the DHFs consistently updated and compiling them as per the Regulatory requirements. Though organizing the DHF together takes a considerable effort, than anticipated, the above-mentioned points can give you a better perspective on compliant DHF process. Avoid Regulatory Authorities warnings and ensure your DHF is organized, accessible and updated. Consult a proven Regulatory expert. Stay informed. Stay compliant.



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