Design Verification Testing: The FDA Cares, You Should Too

Design Verification failures are costly, and these costs may be paid not just by development budget and schedule, but may result in rejection of submissions, warning letters, recalls, loss of market share, or in the worse cases, patient harm. Design Verification is one of the most commonly cited sections in recent warning letters issued by the FDA that include findings related to specific sections of the Design Control regulation (21 CFR 820.30).

Design Verification is the process used by medical device manufacturers to ensure that the outputs from the design process meet the requirements specified in the design inputs. Activities such as Tests, Inspections, or Analyses provide objective evidence that the specified requirements have been fulfilled. This paper will examine three categories of design verification test failures and discuss what can be done to prevent them.