Last Friday we looked at some of the circumstances that have led to the recent influx in FDA recalls. But what this conversation really begs is some examination of how we can approach the situation as communicators.
After years of working with manufacturers as they deal with recalls, I thought I would share the top five tips you may find helpful.
- Do not assume that quality or compliance issues will never reach the recall stage. Once a device is on the FDA’s radar, it is not likely to fade away. In this day and age, it is more appropriate – and helps companies to be ever ready – to assume that a recall is imminent.
- Be patient. These situations are more akin to marathons than sprints. They will not necessarily be resolved in a matter of days or weeks, but more likely months or even years. Settle in for a long haul.
- Be as open, transparent and responsive in all communications with the agency as possible.
- Communicate frequently with customers and other stakeholders. Keep them informed as to how you are assessing any problems. Reach out to them proactively and respond to their inquiries quickly and efficiently.
- Ensure that your employees, at all levels, are informed as well. In particular, keep your sales force and those working on the “front lines” with customers up to speed on the situation and have the tools and resources they need to communicate.






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