Are You Recall Ready? FDA Expects You to Be

March 21, 2022By Philip Won & Lisa M. Baumhardt, Senior Medical Device Regulation Expert & Anne K. Walsh

All companies dread the logistics, cost, and reputational harm associated with conducting a recall when necessary to remove or correct products in the field.  But the more prepared a company is for a potential recall, the less pressure it will feel when a situation necessitates taking action.  To clarify what preparations companies should take to more seamlessly manage a recall, on March 2, 2022, FDA published its Final Guidance Document on Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C.

The Guidance provides detail on a recalling firm’s responsibilities, preparations, and communications and how the Agency can assist a firm with carrying out its recall responsibilities.  The Guidance applies to voluntary recalls of any food, drug intended for human and animal use, any cosmetic, biological, and tobacco product intended for human use, and any item subject to a quarantine regulation under 21 CFR part 1240.

What is a recall?  The guidance defines a recall as a firm’s removal or correction of a marketed product that the FDA considers to be in violation of the laws it administers and against which the Agency would initiate legal action, e.g., seizure.  But FDA notes that the same principles could apply to a company’s action even if it does not rise to the level of a recall, e.g., market withdrawals.  Almost all recalls are conducted on a voluntary basis by the manufacturer.  FDA maintains a database for recalls of FDA-regulated products based on information gathered from press releases and other public notices.

“It is critical for firms in a product distribution chain to be “recall ready.””

The Guidance emphasizes that firms need to be “recall ready.”  The Guidance provides practical guidelines for both firms and direct accounts.  For example, firms should identify and train appropriate personnel with recall-related responsibilities and establish a recall communications plan.  In recognition that hard copy communications are slower and more cumbersome, FDA recommends that firms use electronic communications, as they lay out the details of the electronic means here, to notify the public about recalls.  The Guidance highlights that the firm should identify specific points of contact for internal communications, communications with FDA, and communications to direct accounts or the public ahead of time and maintain draft templates for prompt communication.  FDA has model recall communication templates available here that firms can utilize.

Firms should identify any reporting requirements for distributed products and know in advance whether their product is associated with any legal or regulatory requirements to make a report to FDA.  Firms also need to maintain distribution records to facilitate identifying the direct accounts that received the recalled product by name, physical address where the product was delivered, and contact information.  Whether required or not, distribution records should be maintained by the recalling firm to locate the products being recalled.  Distribution records should be retained for a time period that exceeds the shelf life or expected life of the product and at least the length of time specified in applicable record retention regulations.  Product coding (e.g., unique device identifier for devices, product identifier for drug products) is helpful for the identification of the recalled products, but it may also help a recalling firm accurately limit the scope of recall.

The Guidance also provides recommended procedures for initiating a recall and performing actions related to initiating a recall.  For instance, the Agency recommends that firms prepare, maintain, and document written procedures for initiating a recall and performing actions related to initiating a recall.  This effort could help minimize delays created by uncertainty about what actions to take when a firm decides to initiate a recall, thereby reducing the amount of time a violative product is on the market.  An effective written procedure should carefully delineate (i) the plans of ceasing distribution, shipment, and/or sales of the affected product, (ii) a recall strategy, (iii) communication strategies to notify direct accounts about the product being recalled, including what should be done with respect to the recalled product, and (iv) a communication plan to notify the public about a product that presents a health hazard, when appropriate.

If there is an indication of a problem with a distributed product, FDA recommends that all firms should implement procedures to (i) identify indicators that there may be a problem with a distributed product, (ii) investigate the problem, (iii) make decisions and take action, and (iv) consult with FDA about the problem.  Of note, FDA emphasizes that the recalling firm does not need to wait for the completion of an investigation before it initiates a voluntary recall.  In addition, if a firm identifies any problem with a distributed product, it should not delay initiation of a voluntary recall pending FDA’s review of its recall strategy or recall communications.  The recalling firm should promptly issue a press release or other public notice.  The details of the procedural guidance regarding press releases and written recall notification letters can be found here.

Finally, the Guidance notes that FDA’s recall coordinators can work cooperatively with a recalling firm to facilitate the orderly and prompt removal of, or correction to, a violative product in the marketplace.  If a recalling firm is located in the United States, it can contact a Division Recall Coordinator within the FDA Office of Regulatory Affairs (ORA).  Note that for recalls of CBER-regulated products, firms should contact the CBER’s Direct Recall Classification (DRC) Program.  If a recalling firm is located outside of the United States and is recalling a product exported to the United States, then the recalling firm should contact ORA Headquarters.

Most FDA-regulated entities have an established SOP that governs the evaluation, decision, notification, and process for conducting a recall.  Although the guidance does not impose new requirements, it provides detail on what these SOPs should address and encourages companies to begin the recall process even if FDA has not agreed with the recall plan:

“A recalling firm need not delay initiation of a voluntary recall pending FDA’s review of its recall strategy or recall communications.”

We recommend companies take another look at their existing SOPs to ensure they would satisfy FDA’s expectations set forth in this guidance.

The saying “Hope for the best, prepare for the worst” applies to recalls.  Manufacturers hope for the best that their products are going to be used safely and effectively for patients and consumers.  At the same time, they should prepare for the worst by being “recall ready.”