During a recent FDA inspection, a medical device manufacturer was cited for failing to implement documented Design Control procedures in accordance with both internal SOPs and FDA requirements. FDA’s observation was unambiguous:
“Your procedure section 7.4.1 states ‘R&D will prepare a design development plan for each project using the Project Plan form… Plans shall be revision controlled for Design Changes… approved by both the … and … Departments.’ However, your firm has not shown documented evidence that the Project Plan form for these devices was completed or that these activities were performed.”
This particular procedural lapse represents a direct violation of 21 CFR §820.30(b), which requires that design and development planning be formally documented, reviewed, and updated throughout the product lifecycle.
Under the FDA’s Quality System Regulation for medical devices, 21 CFR §820.30(b) mandates:
“Each manufacturer shall establish and maintain plans that describe or reference the design and development activities and define responsibility for implementation. The plans shall be reviewed, updated, and approved as design and development evolves.”
The regulation emphasizes traceability, accountability, and iterative documentation as central to ensuring design integrity and product safety. This situation illustrates a recurring compliance pitfall: procedures that exist on paper but are not followed in practice. Designating quality checkpoints throughout the entire product lifecycle is paramount for a sound production system.
