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Compliance Corner: When Is An Action Exempt From FDA's Recall Reporting Requirements?

May 6, 2019, Medtech Insight

Medtech Insight included Pamela Forrest's comments from FDAnews' 16th Annual Medical Device Quality Congress about medical device recalls from a product enhancement. Ms. Forrest said the key question companies should ask themselves is whether their action makes a safe device better or improves existing safety concerns. If the action improves a device's safety, then it's likely reportable as a recall - even if that wasn't the primary purpose of the move. She adds that manufacturers are more likely to stay in the FDA's good graces if they avoid so-called "silent" recalls. In these situations, a company undertakes actions in the field without realizing they need to be reported. "If you're cautioning your users as to how to more safely use your device, you're probably in the realm of a reportable event."

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