Being non-compliant in even a small detail of a regulation can result in the need to perform a recall. For international companies, the task of being compliant is even greater due to the need to be compliant with the regulatory bodies of multiple different markets. Each of the regulatory bodies, the FDA for example[1], has the legal authority to initiate a recall which can cause irreparable damage to a company. Often, a company will initiate a recall themselves, known as a voluntary recall[2], when they detect an issue. A voluntary recall will hopefully allow the company to mitigate the damage.

Recalls can have a drastic impact on not only the company’s financials but their reputation as well. A recall does not have to be a disastrous situation for a company. Unfortunately, having a rudimentary plan is not enough, and having no plan can lead to a worst-case scenario. Proper planning can allow a company to come out of a recall virtually unscathed, a smooth, quick, and efficient recall may even help a company’s reputation.

Integrating recall planning into already established systems will help to avoid disaster. With a proper quality management system already in place integrating the recall plan is not too much of a leap. The FDA outlines the necessary steps a company would need to take in the event of a recall, even going as far as to provide a template for the recall letter[3]. Using those procedures as a base for a recall plan will ensure that a company will meet all FDA compliance requirements in the event of a recall. Even with the guidance provided by the FDA, recall plans can still become complicated very quickly. Understanding all the necessary processes that often need to happen simultaneously can be challenging.

No organization wants a recall, but it is better to prepare to weather a storm rather than be blindsided. The trick is setting up a plan that will allow for all the required recall activities to take place as smoothly as possible. EMMA International can provide consultation services both before and during a recall. From developing a quality management system to assisting with regulatory submissions, EMMA can help bring your medical product from concept to commercialization. Give us a call at 248-987-4497 or email info@emmainternational.com to get in touch with our team of experts today.

[1] FDA (September 2018) What is a Medical Device Recall? Retrieved on 10/12/21 from: https://www.fda.gov/medical-devices/medical-device-recalls/what-medical-device-recall

[2] FDA (September 2020) Recalls, Corrections and Removals (Devices) Retrieved on 10/12/2021 from: https://www.fda.gov/medical-devices/postmarket-requirements-devices/recalls-corrections-and-removals-devices

[3] FDA (November 2020) Industry Guidance for Recalls Retrieved on 10/12/2021 from: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/industry-guidance-recalls

Gabe Kadoo

Gabe Kadoo

Mr. Kadoo is a Quality Engineer at EMMA International. He has experience in statistical analysis, performance improvement, quality assurance, and value stream mapping in the clinical setting. Mr. Kadoo also has experience as a clinical researcher and medical technologist. Mr. Kadoo holds a Bachelor of Science in Biology and a Master of Public Administration with a concentration in Healthcare Administration. He is also a Six Sigma Green Belt.

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