The final guidance also explains how FDA works with firms to initiate a voluntary recall.

On March 4, 2022, FDA issued a final guidance to industry and FDA staff regarding the initiation of voluntary recalls under 21 CFR part 7, subpart C. The guidance applies to voluntary recalls of products subject to FDA’s jurisdiction, including any:

1. Food, drug and device (human or animal use);
2. Cosmetic and biological product (human use);
3. Tobacco product;
4. Item subject to a quarantine regulation under 21 CFR part 1240; and
5. Devices that are electronic products regulated as radiology devices (subject to 21 CFR part 892) but not electronic products subject to 21 CFR parts 1003 and 1004.

In short, the final guidance clarifies FDA’s recommendations on how a firm should be prepared to facilitate the timely initiation of voluntary recalls, steps a firm should take if there is an indication of a problem with a distributed product and how to initiate voluntary recalls. The final guidance also explains how FDA works with firms to initiate a voluntary recall.

Specifically, FDA’s final guidance makes clear that it is critical for firms in a distribution chain to be “recall ready.” To accomplish this directive, FDA’s recommended preparations include identifying appropriate personnel, training personnel on their responsibilities, establishing a recall communications plan, identifying any reporting requirements for distributed products, using adequate product coding, and maintaining distribution records. FDA also recommends that firms have written procedures for initiating a recall, which describe all necessary steps and assign actions and responsibilities for those steps. For example, FDA advises that the written procedures should cover how the firm will accomplish:

1. Ceasing distribution, shipment, and sales of affected product(s);
2. Developing of a recall strategy for the particular recall; and
3. Notifying direct accounts about the product(s) being recalled.

FDA encourages use of electronic communications for conveying information about the recall and, in the final guidance, specifically states electronic communications should be used for giving instructions to a direct account regarding disposition of the recalled product, either through return or destruction, and how to respond to the recall notification.

FDA also encourages firms to establish procedures to initiate if the firm suspects a problem with a distributed product. These procedures should detail steps and assign responsibilities for how the firm will identify and investigate the problem and make decisions regarding whether to initiate a voluntary recall and the scope of the recall. If the firm has questions about its examination of the product problem, FDA encourages the firm to consult with FDA during the pendency of the firm’s investigation.

If a voluntary recall is necessary, the final guidance offers recommendations for how a firm should initiate that recall. FDA considers the date of initiation of a voluntary recall to be the date of a firm’s first communication to the public or its direct accounts about the recall. For the content of recall communications, the final guidance notes that 21 CFR 7.49(c) should be followed. The guidance makes clear, however, that a recalling firm should not delay initiation of a voluntary recall pending FDA’s review of its recall communications or its recall strategy. In addition, the recall should be initiated in accordance with 21 CFR 7.46, which specifies that if a product is violative, FDA should be notified immediately with specific information. This code further details the steps FDA will take following review of the notification.

Finally, the final guidance explains that FDA will work with a recalling firm to facilitate removal of or correction to a distributed violative product, especially when the product may present a danger to the public. FDA recall coordinators are available to assist the firm with numerous aspects of a potential recall, including, for example, helping the firm to determine whether the action is a recall as defined in 21 CFR 7.3(g), develop a recall strategy or monitor the disposition of the recalled product(s). The final guidance outlines how a recalling firm can contact the appropriate recall coordinator and details information that a recalling firm should be prepared to provide.

For More Information

If you have any questions about this Alert, please contact Frederick R. Ball, Patrick C. Gallagher, Ph.D., Coleen W. Hill, any of the attorneys in our Life Sciences and Medical Technologies Industry Group or the attorney in the firm with whom you are regularly in contact.

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