February 2005 Post Dinner Summary
The Quality Challenge: Two Sides of the Issue By Susan Alpert, PhD, M.D., Fegulatory Office, Medtronic
Dr. Alpert is able to discuss handling regulatory questions from the perspective of both the FDA regulator and one being audited by the FDA. With this extra insight, she spoke of viewing regulatory issues from both sides of the table.
Changes to a regulated product or process after having been initially approved require that the FDA be notified if the changes are done for reasons including, but not limited to, safety, risk mitigation, use or effectiveness of the product or a change to the product itself. Dr. Alpert gave several case studies where the manufacturer acted under one set of assumptions and the FDA inspector under a different set.
The first case involved a manufacturer reacting to problems in the field. Their customers had difficulty assembling a diagnostic catheter. The manufacturer saw the solution to be reducing the tolerances the catheters were made to. Since they were reducing tolerance in an approved process, they felt no need to bring the change to the FDA’s attention. They took no other action as a result of this problem. This change came to the attention of the FDA in a routine audit and the inspector found this activity as a larger chain of events which should have been brought to the attention of the FDA. From his broader perspective, he cited a change in material prior to the initial reports from the field that may have led to the field assembly problems, he saw the change in tolerance as an act of risk mitigation and he found the company answerable for failing to recall the remaining stock from the field. The manufacturer had viewed this affair from too narrow a perspective and could have avoided some of the FDA’s citations if they had tried to view the situation from the outside perspective of the FDA.
Dr. Alpert gave two more case studies where either the FDA or the manufacturer would have benefited from trying the other party’s point of view. While her cases involved the FDA, the insights could also be applied to other regulatory situations.