Voluntary Recall Guidance Released by FDA

May 19, 2022

The US Food and Drug Administration (FDA) issued its final guidance in April on initiating voluntary recalls for drugs, biologics, and medical devices. Although largely in line with the previous draft guidance issued in April 2019, the agency made changes based on public comments. The non-binding guidance encourages companies in the supply chain to make a series of changes to become “recall ready” in order to streamline recall processes if needed.

According to the Mark Durivage of Quality Systems Compliance LLC, “The guidance suggests that firms consider preparing, maintaining, and documentation procedures for initiating a recall and performing actions related to initiating a recall. The procedures for initiating a recall and performing actions related to initiating a recall should define the responsibilities and describe the required process to perform all appropriate actions, including ceasing distribution, shipment, and/or sales of affected product(s), developing a recall strategy, notifying direct accounts about the product being recalled, including what should be done with respect to the recalled product, providing response instructions to notified direct accounts, including instructions for appropriate disposition of recalled product, and when appropriate, notifying the public about products that present a health hazard.”

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