If you are a medical device manufacturer, it is crucial to have the necessary recall policies and procedures in place to handle a potential field action quickly and effectively. A product recall can be costly and damaging to a company's reputation, so it's essential to be prepared. And while the FDA has the authority to recall any project, voluntary recalls can help keep consumers safe by getting recalled products off the market.
However, this means companies must act quickly to correct the issue and it becomes even more critical to have recall policies and procedures in place when it is a national recall. The FDA has released new guidance on how companies should handle voluntary recalls, including recommendations on product coding and maintaining distribution records. Part of this guidance prescribes that companies should use electronic communications to quickly identify and provide specific product information when alerting consignees and the public about a recall. This measure helps to ensure that everyone in the distribution chain is notified as soon as possible to take appropriate action.
The FDA also says companies should act quickly and begin a recall when public health is in jeopardy and to do so before investigating the cause of the problem. Because recalls can affect supply chains from wholesales and downstream suppliers to vendors, the FDA recommends that companies develop recall procedures to inform their whole distribution chain quickly to rapidly identify affected lots and recall downstream products when necessary.
But are your company policies and procedures in place for a recall? If not, now is the time to develop them. According to the FDA, good company policies for recalls should include:
- Initiating a recall when public health is at risk.
- A plan for notifying the entire distribution chain quickly.
- Informing consignees and the public as soon as possible.
- Maintaining records of product codes and distribution lists.
If you're unsure where to start, the FDA's new guidance on voluntary recalls can help. But don't wait until you have a problem with your recall procedures. Be proactive and put policies and procedures in place now to prepare for a recall. Organizations can improve their company procedures for a possible recall by:
- Issuing guidance on the public availability of lists of retail consignees to begin particular recalls.
- Implementing mandatory recalls when necessary.
- Releasing public warnings and notifications for all FDA-regulated products reiterates a policy to rapidly post new recalls to the FDA's enforcement report.
MEDIcept is an international medical device consulting and regulatory organization that can help you navigate the complexities of the recall process. We're here to help you protect public health and our team of experienced professionals can help you develop policies and procedures to be recall ready. To learn more, explore our services here or contact us directly, and we would be glad to help with all your recall and regulatory needs.
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MEDIcept is an international consulting firm offering a full portfolio of services to the medical device and IVD industry. For over 25 years, our unique consulting practice and multidisciplinary team of former FDA, Notified Body, and industry experts have assisted hundreds of companies of all sizes with innovative, compliant, trusted, and cost-effective Regulatory, Quality, Clinical, and Engineering solutions.
For additional information, please contact Susan Reilly at SReilly@MEDIcept.com.