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FDA, Health Canada Say Robust Recall Plans Needed

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While the degree of risk and a company’s history dictate the level of regulatory scrutiny a device recall audit gets, recall strategies are expected to document supply chain communications down to the patient, FDA and Health Canada officials say. Both agencies plan to issue guidance soon on what evidence is acceptable to show that a company’s recall has been effective. In the meantime, devicemakers must continue to meet recall coordinators’ individual expectations, the regulators said.
Devices & Diagnostics Letter