CDRH ombudsmen David Buckles and Lawrence Romanell are soliciting stakeholder comments on FDA’s use of the term “significant decision.” They are also looking for comments on a draft guidance with expectations of how the center will deal with disagreements over such decisions. Writing in a July 16 “FDA Voice” blog post, the two say, “When it comes to disputes, all stakeholders play an important role in resolution. Therefore, we strongly encourage interested parties to provide comments and suggestions to improve our appeals process to help us meet our goal of providing a fair, equitable, predictable, and transparent means for seeking resolution of disputes.”
Buckles and Romanell say it is their experience that differences of opinion that arise before a final decision is reached usually can be resolved through discussion or mediation. They suggest that if interactive discussion with a lead reviewer, team leader, or consumer safety officer doesn’t resolve the issue, there’s a good chance of success if the stakeholder engages branch and division management in a discussion. “We have never yet had a senior manager turn us down when we’ve asked them to take a look at a situation,” they say, “and we strongly encourage stakeholders to make a good faith effort to connect with management at least through the division level before considering more formal approaches.”
The center has come a long way in standardizing the appeal process and setting consistent expectations internally and externally to ensure that stakeholders with a legitimate dispute receive a fair and impartial hearing by senior management, the post says.
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