The new article describes in detail the aspects to be considered when identifying a medical device recall to distinguish it from other actions.
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The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to distinguishing medical device recalls from medical device enhancements. The document provides additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be considered by medical device manufacturers and other parties involved to ensure compliance thereto. In particular, the guidance addresses the aspects related to the determination of the regulatory status of changes to medical devices depending on their intended purpose and the impact they will have on the safety and performance of the product. At the same time, it is important to mention that provisions of the guidance are non-binding, nor are intended to introduce new rules or impose new obligations. The authority explicitly states that an alternative approach could be applied, provided such an approach is in line with the existing legislation and has been agreed with the authority in advance.
Recall Identification: Key Points
The document provides, inter alia, the questions and answers describing the way a recall can be identified. According to the guidance, the questions to be considered in this respect are the following:
- Is the product in question a medical device? According to the guidance, a recall procedure described therein applies only to the products that meet the definition of a medical device set forth by the respective legislation, while any other products are falling outside the scope of the document.
- Is there an intent to make a correction to the device, or to remove it from the market? In case there is no such intent, the actions cannot be considered a recall. Under the general rule, a recall can include changes to the device design, device labeling (including updating the labeling of a distributed product), and updated marketing materials.
- Is the device subject to changes already available on the market? As explained by the FDA, a recall could be initiated only concerning a medical device already placed on the market, while any changes made to the items remaining under the control of the manufacturer are considered to be a stock recovery, hence, falling outside the scope of a recall concept.
Differentiating Violative Devices from Non-Violative Devices
As it was mentioned before, the concept of “violation” is vitally important in the context of recalls, as it allows one to distinguish recalls from other actions taken to improve the overall performance and safety of the device. According to the explanation provided by the FDA, a recall constitutes an action taken concerning a medical device considered to be non-compliant with the applicable regulatory requirements in terms of safety, quality, and performance. In particular, it is stated that only changes to devices to remedy a violation of the laws administered by the FDA and against which the agency would initiate legal action fall within the definition of a medical device recall. The authority provides an example to illustrate the way such an approach should be applied: if a device is being corrected to address a Quality System violation (21 CFR part 820), then the correction would generally be considered a recall. At the same time, changes made to medical devices that are fully compliant with the applicable regulatory requirements will be considered medical device enhancements.
The document further provides specific questions to be considered when making such a determination. These questions include, inter alia, the following ones:
- Are the changes intended to resolve a failure to meet specifications or a failure of the device to perform as represented? According to the position of the authority, in case the changes to a medical device are to be made to resolve a failure to meet specifications or operate as initially intended, such changes will be considered a recall. As further explained by the FDA, failure of the device to operate as intended includes, an increase in overall failure rate, an increase in a single failure mode, or the identification of a new failure mode. Hence, any changes introduced to address the above issues will constitute a device recall and should be subject to respective regulatory requirements and procedures. The guidance also provides several examples to demonstrate the way the approach should be applied.
- Is the labeling for the device to which [the manufacturer] is considering making changes false or misleading, does it fail to bear adequate directions for use, or does it otherwise violate the FD&C Act or FDA regulations? By the respective regulations, the devices having issues with the labeling (i.e., containing false or misleading information) are considered to be misbranded and, consequently, violate the rules set forth therein. Thus, changes intended to address such issues will be considered a medical device recall.
- Are there any other non-compliances with the FDA regulations? The authority additionally emphasizes that a party responsible for a medical device should carry out a rigorous assessment of the changes to be introduced, paying special attention to the intended purpose of such changes. As explained by the FDA, should the results of such an assessment indicate that the change is made to correct or remove a violative marketed device to bring it into compliance with the laws administered by FDA, then the change would likely constitute a medical device recall.
In summary, the authority describes in detail the approach to be applied when identifying a medical device recall and distinguishing it from any other actions. The guidance also highlights the key points to be taken into consideration concerning compliance with the applicable requirements in terms of safety, quality, and effectiveness.
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