The new article describes in detail the main concepts used in the context of medical device recalls and enhancements in terms of determination of their legal nature and actions to be taken by the parties involved.
The Food and Drug Administration (FDA or the Agency) has published a guidance document dedicated to distinguishing medical device recalls from medical device enhancements. In particular, the guidance describes the approach to be applied when determining the legal nature of changes made to a medical device placed on the market based on their nature – whether such changes are to be implemented to address specific safety-related concerns or just to improve the overall safety or performance of the device. The said determination will impact the approach to be applied by the parties involved, including the registration holder and regulating authority.
It is also important to mention that FDA guidance documents are non-binding in their legal nature, nor are intended to introduce new rules or impose new obligations, but rather to provide additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be considered to ensure compliance thereto. Moreover, the authority also states that an alternative approach could be applied, provided such an approach is in line with the current legislation and has been agreed with the authority in advance.
First of all, the authority provides definitions of the most important terms and concepts used in the context of the guidance to assist with the interpretation of the respective regulations. The terms explained in the guidance include, inter alia, the following ones:
- Recall – a firm’s removal or correction of a marketed product that the Food and Drug Administration considers being in violation of the laws it administers and against which the agency would initiate legal action, e.g., seizure. The recall does not include a market withdrawal or a stock recovery. The authority also mentions that routine servicing of medical devices supplied to customers or enhancements are falling outside the scope of recalls. The key point here is a violation – the device subject to recall should be removed from the market due to its non-compliance to ensure public health protection and the safety of patients.
- Correction stands for repair, modification, adjustment, relabelling, destruction, or inspection (including patient monitoring) of a device without its physical removal to some other location.
- Removal stands for the physical removal of a device to some other location for repair, modification, adjustment, relabelling, destruction, or inspection.
- Violation, for the guidance, means a situation when the medical device fails to comply with the applicable regulatory requirements for safety, quality, and effectiveness.
- Device enhancement is a term that is not defined in the existing regulations, so the authority provides a new definition to be used when interpreting provisions of the applicable legislation. For the guidance, a device enhancement stands for (1) a change to improve the performance or quality of a device that is (2) not a change to remedy a violation of the FD&C Act or associated regulations enforced by the Agency. As further explained by the FDA, device enhancements include, but are not limited to, changes designed to better meet the needs of the user, changes to make the device easier to manufacture, changes to improve a non-violative device’s safety or performance, and changes to the appearance of the device that do not affect its use.
- Stock recovery means a firm’s removal or correction of a product that has not been marketed or that has not left the direct control of the firm, i.e., the product is located on premises owned by, or under control of, the firm and no portion of the lot has been released for sale or use.
- Market withdrawal stands for a firm’s removal or correction of a distributed product that involves a minor violation that would not be subject to legal action by the Food and Drug Administration or which involves no violation, e.g., normal stock rotation practices, routine equipment adjustments, repairs, etc. The authority explicitly states that market withdrawal should not be considered a recall.
- Routine servicing means any regularly scheduled maintenance of a device, including the replacement of parts at the end of their normal life expectancy, e.g., calibration, replacement of batteries, and responses to normal wear and tear. At the same time, the FDA additionally emphasizes that any repair initiated in response to the specific issues or malfunctions of the device, and is not regular, will fall outside the scope of routine servicing. Thus, the reason for initiating a repair should be taken into consideration when determining the regulatory status of such an action.
Apart from the definitions outlined hereinabove, the authority also provides examples of the way the said definitions should be applied in real-world situations. However, it is important to mention that these examples are not exhaustive and are provided for illustrative purposes only, so the regulatory approach to be applied should be determined on a case-by-case basis.
When providing definitions of the most important terms and concepts, the authority emphasizes the most important criteria to be taken into consideration when determining whether the actions in question should be considered a recall or enhancement. According to the guidance, most attention should be paid to the initial grounds for such actions to be taken. If the reason for making changes to the device already placed on the market is to address specific issues or malfunctions identified, this will be considered a recall. At the same time, in case actions are taken to improve the overall performance of the device, its safety, and effectiveness based on recent technological development or new technologies without the intent to mitigate new risks identified, such actions will be considered enhancements.
In summary, the present FDA guidance provides definitions of the most important terms and concepts used in the context of medical device recalls and enhancements to assist the industry with the correct interpretation of the applicable regulatory requirements. The authority also highlights the key points to be considered when determining the regulatory nature of the changes to a medical device based on the reasons for and intended purposes of such changes.
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