According to the U.S. FDA, medical device design controls “control the design process to assure that devices meet user needs, intended uses, and specified requirements.”
For medical device manufacturers, it is critical to have robust design controls as they help ensure quality, safety, and effectiveness of the end product. Design controls are particularly important for Class II and Class III medical devices while most Class I devices are exempt.
For one, in the United States, 21 CFR 820.30 mandates that a robust design control system include human factors analysis under design input, design verification, and design validation.
Technical documentation for design controls includes summary reports, material certificates, plans, protocols, and reports.
According to one FDA investigator, if there are concerns about a manufacturer’s quality system, the investigator may take a closer look at areas such as design controls.
Related: There were 1,272 FDA 483 observations for design controls involving medical device GMP operations over the past ten years. Contact Redica to see how we can help you stay on top of the latest GMP inspection trends to make your inspection preparation easier.
Design Control Warning Letter Citations
For examples of FDA warning letter citations involving medical device design controls, check out the following from over the years.
- A manufacturer of thermographic products received a warning letter in February 2019 due to lack of design control features.
- Design controls at a manufacturer were found inadequate as the design history file did not include design inputs among other requirements.
- A BIMO inspection in October 2019 found that design controls were not adequately implemented at a Hungarian device firm.
Additional Design Control Resources
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