FDA investigators do get trained to the regulations as well as to FDA’s guidance on design controls. They do not necessarily have experience with a medical device firm that has done good design and has fully compliant design control processes and procedures. Their understanding of good design is learned primarily by inspecting medical device firms. They may not always have an objective or unbiased understanding of good design. They will be able to determine whether your procedures appear compliant. From your post-market data (complaints, production non-conformances, MDRs, recalls or corrections and removals and your design and manufacturing changes) they will be able to determine whether you do or do not have a basic understanding and control over your designs.

The more changes you make due to design issues or the more complaints, MDRs, corrections or removals or recalls you have relative to design issues, the more likely they are to believe that you do not practice good design and development. They do realize that you cannot find all of your design flaws even with good design verification and validation, however the design flaws that are found in the production or post-production environment should be design flaws that would reasonably not be something you might have found with good design verification and validation practices.

Denise Dion is the vice-president, regulatory and quality services at EduQuest, where she provides advice and guidance regarding FDA's regulation of drugs, biologics, medical devices, and food.