The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published a guidance document dedicated to medical recalls, corrections, and removals for medical devices. The document provides an overview of the basics of recalls, highlights the main points related to the recall strategy, and clarifies other important aspects to be considered by medical device manufacturers and other parties involved in operations with medical devices.
Table of Contents
Due to their legal nature, guidance documents issued by the FDA are intended not to introduce new rules and requirements but to provide additional recommendations and clarifications. Alternative approaches could be applied, provided they comply with the relevant regulatory requirements.
Recall Letter
According to the general rule, an entity that initiates a recall is obliged to duly notify any and all parties involved in operations with the medical device subject to recall. How such information should be communicated depends on the risks associated with the device in question and also on the strategy of the recall in general. As stated by the FDA, a recall communication is intended to inform the parties involved on the following:
- The product in question is subject to a recall;
- Further distribution or use of any remaining product should cease immediately;
- Where appropriate, the direct account should in turn notify its customers who received the product about the recall;
- Provide instructions regarding what to do with the product.
As explained by the regulating authority, the information outlined above could be communicated in any way the entity initiating a recall finds appropriate and efficient enough to ensure all the parties involved would receive it without undue delay. The FDA additionally emphasizes the importance of special signs intended to warn additional attention: “medical device recall” and “urgent” (in case of Class I, Class II, and in certain cases, Class II recalls as well), preferably in bold red type. These communications could be accompanied by ordinary calls.
The guidance further provides recommendations to be followed in order to ensure the efficiency of recall communication. According to the guidance, a recall communication should be brief and precise, contain the information necessary to identify the particular medical devices that are subject to a recall (e.g., lot numbers or codes), and also provide detailed enough clarifications regarding the grounds for a recall. Additionally, a recall notification should describe the way the recipient should act with regard to the recall request, and also the way the recipient could contact the entity initiating the recall to notify about the medical devices in question available.
The FDA explicitly states that the recall communication should not contain irrelevant qualifications, promotional materials, or any other statement that may detract from the message. Should some of the recipients of such communications fail to respond, the entity initiating a recall could contact them again in order to ensure the important information about a recall has been duly received and taken into consideration. According to the guidance, the entity initiating the recall may also contact the authority prior to sending recall communications to discuss their form and content. The entity which receives a recall communication would immediately follow the instructions provided therein and also notify the entities below in a supply chain about the recall initiated.
Recall Status Report
As a part of recall monitoring, the regulating authority requires the entity initiating a recall to provide periodic recall status reports. In such a way, the regulating authority intends to track the progress. According to the guidance, the frequency of reports should depend on the risks associated with the medical device in question and the urgency of the recall. In most cases, such a report should be submitted once in 2 or 4 weeks – the Agency will specify the applicable reporting period for each particular case.
The information provided in a periodic recall report should cover the following details:
- Number of entities involved that were duly notified about the recall by the initiating entity (including a description of when and how they were notified);
- Number of the entities that have provided a response (including the details about the quantity of medical devices subject to recall held by such entities at the moment when a recall communication has been delivered);
- Number of entities that have not provided any response (the authority further reserves the right to contact them itself);
- Number of medical devices returned by each entity involved;
- Numbers and results of effectiveness checks that were made;
- Estimated time frames for completion of the recall.
It is also important to mention that the obligation of the entity initiating a recall to submit periodic recall reports will remain applicable until the regulating authority terminates a recall.
Recall Termination
As it is described in the present FDA guidance, a recall will be terminated when FDA determines that all reasonable efforts have been made to remove or correct the product in accordance with the recall strategy, and when it is reasonable to assume that the product subject to the recall has been removed and proper disposition or correction has been made commensurate with the degree of hazard of the recalled product. Once the above is determined by the regulating authority, it will provide the appropriate notification to the entity initiating the recall. The latter is also entitled to submit a written request to terminate the recall on the basis of reaching the criteria outlined above. Such a request should be accompanied by the latest recall status report containing information that demonstrates the effectiveness of the recall.
Additional Guidelines
Apart from the main points described above, the present FDA guidance on recalls addresses some additional aspects associated thereto. For instance, the FDA acknowledges that a recall can be disruptive of a firm’s operation and business, but it also states that there are several steps a firm can take in advance to minimize this disruptive effect. According to the guidance, the entity initiating a recall can:
- Develop the appropriate plan in advance to be able to apply it once necessary;
- Ensure the devices are identifiable enough to recall specific lots;
- Duly maintain the distribution records in order to be able to easily identify the parties involved in a recall. Such records should be kept within a period of time exceeding the intended lifetime of the medical device.
By considering the abovementioned points, medical device manufacturers would be able to conduct recalls in a fast and efficient manner.
In summary, the present FDA guidance provides detailed recommendations to be taken into consideration with regard to recalls of medical devices placed on the US market. The document describes the procedures to be followed in order to ensure the effectiveness of recalls and compliance with the applicable regulatory requirements.
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