Resolving Regulatory Tension: 7 Takeaways from a CDRH Ombudsman

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ARTICLE SUMMARY:

Ken Skodacek, deputy ombudsman for FDA’s device center, talks about what companies should expect from his office and tips for avoiding and addressing conflicts with FDA.

Ken Skodacek describes part of his job as “trying to help people reset their perspective, gain a sense of calm, take a few deep breaths, and then dive in to find resolution to whatever the problem is.”

It sounds like a good therapy session, but Skodacek is focused more on fulfillment of the regulatory rather than personal variety. As the deputy ombudsman for CDRH, he’s someone a company can go to when it doesn’t quite know where to turn in its FDA path.

A manufacturer and FDA reviewer don’t see eye to eye on a data point, there’s a communication breakdown over a policy interpretation, or a company simply worries about rubbing the agency the wrong way with an inopportune question. All of these are pretty natural dynamics between a regulated entity and its regulator. Disagreement, confusion, or, at least, some apprehension is likely to crop up at some point, even with the best of intentions on both sides. The trick for a company is to not let it derail a device development effort.

“I always try to encourage everyone to step into the mindset of the person who they're working with or disagree with.”

Ken Skodacek, CDRH Deputy Ombudsman

That’s where the CDRH Ombudsman’s office can come in, offering ideas for engaging more effectively with FDA and sometimes diving deep into conflict resolution strategies. “We realize that manufacturers might have a perspective, and the agency has a perspective, and it's not unusual for those perspectives to diverge or not exactly align in all cases,” Skodacek said in an interview. “Part of our role is to build the bridges between the two sides, such that they can work through those conflicts on their own.”

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