Design Change: How Does FDA Define It?

Q: From an FDA viewpoint and your own experience, how would you recommend we define a “design change” in our design control procedures?

A: FDA has said that any change to the finished, packaged and labeled device should be considered a design change. It’s important to note that product packaging and label/labeling are considered part of the final device design.

Under the Quality System Regulation (21 CFR Part 820), FDA also incorporates the concept that design change should not and cannot adversely impact product performance as well as things such as reliability and durability.

[pullquote align=”right” cite=”” link=”” color=”” class=”” size=””]FDA expects that any change to a Design Output should be considered a design change.[/pullquote]

Furthermore, based on my knowledge of FDA 483 observations, Warning Letters and recalls, FDA also expects that any change to a Design Output should be considered a design change. Design output includes the complete Device Master Record (DMR), qualification of suppliers, manufacturing methods, and manufacturing materials.

This expectation stems from a long history of changes that resulted in bad product design in the marketplace. The Agency saw device-makers making changes to suppliers, manufacturing methods, manufacturing materials, etc., that negatively impacted the physical design of a device or the intent of its design. In some cases, these changes led to deaths.

The only exception would be if you know — before making the change — that the change to a Design Output element absolutely will not impact the final finished, packaged and labeled device.

FDA expects you to assess all changes for their likely impact on design, and it also expects design engineers to be involved in making that assessment.

To summarize, in the training I provide on design controls, I use this definition:

A change that may affect the physical medical device (which includes its packaging and labeling), its accessories, manufacturing processes, test methods, or acceptance criteria or procedures is considered a change that could affect design and should be handled as a design change.

Answered by Denise Dion, Vice President of Regulatory and Quality Services for EduQuest, who served 18 years at the U.S. FDA as an expert field investigator, helped to develop FDA’s Quality System Inspection Technique (QSIT), and was a member of FDA’s Design Control Inspection Strategy Team. Denise also is the lead instructor of EduQuest’s two-day training class on Design Control for Medical Devices: Meeting FDA’s 21 CFR Part 820.30 Rules for Quality Design and Manufacturing.

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