Rita Hoffman is the managing partner RHoffman Inc. and has more than 36 years of FDA experience across the device, drug, and veterinary industries. Until recently, she served as recall branch chief for CDRH. She recently answered questions on building a recall strategy for medical devices. 

1. What does “recall strategy” mean?

“Recall Strategy” is a planned course of action to be taken in managing and implementing a specific recall. This action is distinguished from the process a firm takes when deciding whether a product needs be recalled. The elements of this include communications with FDA on the depth of the recall, publicity, and process for effectiveness checks.

2. What should the recall strategy take into account?

• Results of the firm’s health hazard evaluation (risk assessment).
• Ease in identifying the product being recalled.
• Degree to which the product’s deficiency is made clear to the user, consumer and consignees.
• Degree to which the recalling product remains unused in the marketplace.
• Continued availability of essential product.

3. What aspects of your recall strategy does FDA expect to discuss with you during your first contact with the district recall coordinator?

• Information about the product being recalled including--the nature and scope of the problem, affected lots and labeling.
• The proposed recall strategy (proposed action) availability of acceptable alternative product to address both patient risk and the customer’s needs, (if a medically necessary product is involved).
• The current status of the firm’s investigation.
• A draft of a well- developed public notification letter. (However be prepared to negotiate the type and content of your communication that your firm will be sending.)
• The fact that you will be notifying international customers and authorities.

4. What will likely happen after you have implemented a properly executed recall strategy?

An FDA investigator will inspect your firm, either immediately, or after the recall is conducted. Some customers will refuse to return the product or discontinue using the equipment even after your sales people have explained the risk. To minimize incomplete effective checks you will have to develop and implement a well planned first and alternative course of action for receiving responses from users, consignees and customers. Also, some third parties will not properly dispose some of your products.

5. How can firm developed policies, training and procedures for effective implement a recall strategy?

Firms should consider developing in-house programs to training all staff on each aspect for implementation of an effective recall. The training should include recall readiness assessment, recall plan development, staging a mock recalls, recall execution and results. Having a recall management plan in place before it is needed will assist employees in the knowledge of their roles and responsibilities during the recall process and will avoid a “Management by Crisis” scenario.

Editor's Note: Rita Hoffman will be speaking on Devising a Recall Strategy: Dealing with Removals and Corrections at the upcoming MD&M West trade show and conference. Join her and other regulatory experts February 11-14, in Anaheim, CA. 

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Rita Hoffman, RAC is managing partner at RHoffman, Inc. She has an intimate understanding of FDA regulatory and compliance issues from the perspective of both FDA and regulated industry. As an FDA compliance consultant, she provides clients with regulatory insight, advises on critical compliance deficiencies, performs compliance and new product audits, provides insight and guidance on recall strategies to the medical device industry, and advises on jurisdiction determinations for combination products. Until January 2011, Hoffman served as recall branch chief for CDRH, where she was responsible for oversight and review for all medical device recalls. Ms. Hoffman held several positions including the Center for Drug Evaluation and Research (CDER) Jurisdiction Review Officer (providing guidance on drug/device product designation, combination products and co-packaging), Acting Associate Ombudsman, Small Business Liaison, and was a Policy Analyst for eight years in the Office of the Commissioner.