Medical Device Development

Moving Your Concept Past The FDA Requires Documentation

There is always a market for innovative medical equipment that advances healthcare, no matter how small the application. Maybe you have an idea that would improve an already existing device or a diagnostic apparatus that would revolutionize the patient experience. If you’re ready to transform your idea into a tangible product, you are at the beginning of possibly a long and sometimes complicated process of acquiring regulatory approval. Documenting every step of the way in a design history file (DHF) is an essential part of creating a new product that will meet with regulatory requirements.

What Is a Design History File?

The DHF is required by the U.S. Food and Drug Administration (FDA). It is a document that details every step of the development process and their guidelines are laid out in this FDA Code Title 21, section 820.30. The FDA requires this document to verify that you and your team’s methods fall in line with regulations for every component of the design control process, which includes the following:

  • Design and development planning
  • Design input
  • Design output
  • Design review
  • Design verification
  • Design validation
  • Design transfer
  • Design changes
  • Design history file

This recording process should generate a veritable mountain of documentation that is compiled into the DHF. The final file should be gathered into one document, that should also include an index for the researcher to follow easily.

How Will It Enhance the Development Process?

As a medical device designer, we know how complex the development process can be for most inventors. A DHF will help you keep everything organized. Knowing that this thorough documentation is required will remind you to keep meticulous notes. These notes can help to overcome obstacles that arise future along in the process by allowing you to backtrack and make adjustments where needed. Also, as you prepare to submit your medical device to the FDA, you can use the DHF to double check your methods. While the FDA requires this file for their own work, it is equally useful on your end.

How Will It Help Meet FDA Requirements?

When the FDA reviews your device, a lead reviewer follows and acceptance checklist that is very comprehensive and includes a review of the digital history file. An agent will review your DHF to make sure your product design & development process was properly documented and every medical device designer involved complied with applicable regulations. One of the main reasons for developing history files is to ensure that product designers for healthcare devices follow a strict code of ethics and product safety is of paramount importance during the engineering design process.

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