When device modifications could affect safety and effectiveness, a premarket notification submission is required.
Adulterated product and QSR compliance issues create the perfect storm for a warning letter.
Even what may appear as simple design changes need to be reviewed for the need to repeat design validation.
In this fourth and final foray into Subpart C – Design Controls, Dr. D will review the last three subsections; (h) design transfer, (i) design changes, and (j) the design history file (DHF), located within section 820.30. These final three elements of design control are just as important as the previous subsections dissected as part of Devine Guidance.