“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.
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.
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.
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.