Q: I need guidance on 21 CFR 820.30(d), where the regulations talk about Essential Design Outputs. I’ve been getting a lot of hot air about this requirement. Could you give some examples, especially for an electromechanical device and a sterile disposable device?
A: Essential design outputs are similar to what FDA used to refer to as critical components — but the Agency’s concern now goes beyond the component level.
The output of design includes drawings, production processes, work instructions, acceptance tests and criteria, packaging, labels, labeling, materials, and more.
For an electromechanical device intended to monitor a body function, provide accurate readings, and alert the user if readings fall outside of an acceptable level, then essential design outputs are the portions of the device that collect and analyze the data and control the alarm functions. Specifically, these might be the control board, software that interprets and converts the incoming data signals and displays the results, alarm speakers and visual displays, and software that controls the alarm.
If the product is sterile, then the outputs that ensure sterility are essential. These might include the bioburden specifications, cleanroom designation, packaging that creates and maintains the sterile barrier, the packaging operation, and the sterilization process itself.
[pullquote align=”right” cite=”” link=”” color=”” class=”” size=””]To meet [FDA’s rules for essential design outputs], you must determine what’s essential to product safety and performance.[/pullquote]
So to meet 820.30(d), you must determine what’s essential to product safety and performance. For safety, use the product risk assessment document. For performance, use some type of fault tree analysis. But start first with the product labeling — what is the product’s intended function and performance? What are the parts, dimensions, tolerances, and materials essential to ensure the device will perform safely and effectively?
Answered by Denise Dion, EduQuest’s Vice President of Regulatory and Quality Services, former FDA expert investigator and member of FDA’s Design Control Inspection Strategy Team. Denise also is the lead instructor for EduQuest’s training class on Design Control for Medical Devices: Meeting FDA’s 21 CFR Part 820.30 Rules for Quality Design and Manufacturing and the author of the free EduQuest Advisory entitled Correlation (Cross-Walk) between 21 CFR Part 820 and Best Practices in Design Controls.