The Food and Drug Administration (FDA or the Agency), the US regulating authority responsible for marketing approval and post-market monitoring and surveillance in the sphere of medical devices, has published an official notice dedicated to special action taken to ensure public health protection in the case of failure of medical devices and safety issues associated thereto. In particular, the FDA highlights the most important aspects related to recalls, corrections, and removals.
According to the guidance, a recall is defined as an action performed in order to remove a medical device from the market in the event the device fails to comply with the applicable regulatory requirements. It is important to mention that medical device manufacturers and distributors should initiate recalls on a voluntary basis if the product they are responsible for creates additional risks for the patients and exposes them to certain hazards. However, in certain cases, the Agency as a regulating authority in the sphere of medical devices is entitled to issue a recall order to force the party responsible for a medical device to initiate a recall. How a recall should be carried out is prescribed by regulation 21 CFR 7, while additional aspects related to the participation of the FDA are addressed in regulation 21 CFR 810 and section 518(e) of the Federal Food, Drug, and Cosmetic (FD&C) Act.
First, the FDA provides the definitions of the most important terms and concepts used in the context of recalls, including the following:
- Recall stands for a firm’s removal or correction of a marketed product that the FDA considers to be in violation of the laws it administers and against which the agency would initiate legal action, e.g., seizure.
- Recall strategy is a planned course of action to be taken in conducting a specific recall, which addresses the depth of recall, need for public warnings, and extent of effectiveness checks for the recall.
- Recalling firm is the firm that initiates a recall or, in the case of a Food and Drug Administration-requested recall, the firm that has primary responsibility for the manufacture and marketing of the product to be recalled.
- Apart from those listed above, the FDA notice on recalls, corrections, and removals provides the definitions of such terms as “marketing withdrawal,” “risk to health,” “routine servicing,” and “stock recovery.”
The guidance further describes voluntary as per regulation 21 CFR 7. The Agency states that voluntary recall is an alternative to the removal of medical devices from the market in accordance with a court order initiated by the FDA. In either case, the regulating authority will closely monitor the actions taken by the responsible entity in order to evaluate their effectiveness and sufficiency. As mentioned, the entity responsible for a medical device may initiate a recall voluntarily or on the basis of the appropriate request filed by the regulating authority. In most cases, the Agency presumes that the responsible entity will duly initiate a recall itself. A recall order should be used only in extraordinary cases. Should this be necessary, the regulating authority will communicate the appropriate order to the entity primarily responsible for the device.
The authority also mentions that the concept of recalls does not cover withdrawals – special actions initiated by the medical device manufacturer or distributor in the event of minor non-compliances that are not associated with significant risks for public health and could be settled without initiating a recall. The Agency additionally emphasizes that the general rules on recalls prescribed by regulation 21 CFR 7 do not cover electronic products emitting radiation and are regulated under 21 CFR 1003.
Health Hazard Evaluation
When considering the necessity of a recall, a responsible entity shall evaluate the health hazard associated with the medical device in question.
The aspects to be taken into consideration include the following:
- Whether the failure of a device to operate as intended has already resulted in injuries and harm caused to patients;
- Whether the current situation can result in exposing patients to additional health hazards (the decision made should be justified and supplemented by scientific documentation);
- Distribution of risks depending on the target population segments;
- Significance of health hazards associated with the device;
- Potential consequences associated with the health hazards.
Depending on the aforementioned factors, the Agency will also determine the appropriate classification of a recall (Class I, II, or III) in order to indicate the significance of health hazards associated with the medical device in question.
As mentioned, all recalls could be divided into three classes depending on the health hazards associated thereto. The Agency describes these classes in the following way:
- Class I – the use of a medical device could probably result in serious adverse effects;
- Class II– the use of a medical device could result in adverse effects that are temporary in their nature or could be medically reversed;
- Class III – the use of a medical device is less likely to lead to any significant negative consequences.
It is important to mention that here the Agency employs a reversed order in comparison to medical device classification where the risk increases with the class of a medical device.
Once the decision to initiate a recall is taken, a responsible entity shall develop a recall strategy. The factors to be considered shall include the following:
- Results of health hazard evaluation,
- Ease in identifying the product,
- Degree to which the product’s deficiency is obvious to the consumer or user,
- Degree to which the product remains unused in the market-place,
- Continued availability of essential products.
A developed recall strategy should be submitted to the FDA for review. The latter is entitled to suggest changes it finds reasonably necessary. It is also important to mention that even if the responsible entity is obliged to conduct recall strictly in accordance with the recall strategy as approved by the FDA, the delays in strategy review should not cause delays in its actual implementation.
A recall strategy shall cover such aspects as the depth of recall based on hazards associated with the medical device in question, public warning to be issued by the responsible entity, and effectiveness checks performed in order to ensure the effectiveness of measures taken.
In summary, the FDA notice on recalls and other corrective actions outlines the aspects to be considered when determining the necessity of a recall and also highlights the most important points associated thereto. The document provides an overview of the regulatory requirements related to the voluntary recall the entity responsible for a medical device shall duly initiate if the device fails to perform as intended in order to ensure public health protection and safety of patients.
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