What To Do If You Disagree with FDA's Classification of Your Recall

If you don't agree with FDA's classification of your medical device recall, communication is the best strategy.

At MD&M East yesterday, representatives from FDA shed some light on the subject of how the agency classifies medical device recalls.

Bill MacFarland, supervisory biomedical engineer with FDA, said the process begins with a compliance officer who initially review the recall package from the manufacturer. From there, the officer must determine whether the recall warrants a Health Hazard Evaluation, whereby it is referred to a medical officer who recommends a risk classification, or if the officer can simply look through a database for similar recalls to make a determination.

Daniel Dill, a program analyst with the division of manufacturing quality recall group in FDA’s office of compliance, said in determining which of those two steps to take, he typically looks at the patient population, the device itself, the device's design, and the device's purpose. “I think about it from the patient’s perspective, what is the worst case scenario,” he said.

But once a risk classification is assigned, what options do companies have if they disagree with the agency’s decision?

“That doesn’t happen very frequently,” MacFarland insisted, adding that before a recall classification is determined there have been numerous opportunities for interaction between FDA staff and the manufacturer.

“Our compliance officers plus a medical officer are on the phone with the firm to determine what event occurred, when it occurred, what are the severity issues, and how that firm got a particular view of the risk versus our view of the risk,” MacFarland said.

If the two parties are still at odds, he said companies can go through a recall coordinator to discuss the reason and rationale for the recall classification. The purpose, he said, is to make sure FDA and the manufacturer understand where the other is coming from.

“We want to make sure we’re disagreeing about the same thing,” MacFarland said.

Jamie Hartford, managing editor, MD+DI



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