The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices and other healthcare products, has issued a guidance document dedicated to distinguishing medical device recalls from medical device enhancements.

The current version of the document was published in October 2014. Due to its legal nature, the FDA guidance does not introduce any rules or requirements itself but provides additional clarifications on the applicable legislation, as well as recommendations to be considered by the parties involved. Moreover, the Agency states that an alternative approach could be applied, provided such an approach complies with the applicable regulatory requirements and has been approved by the authority in advance.

Regulatory Background 

According to the present FDA guidance, a recall is defined as a firm’s removal or correction of a marketed device that the Agency considers to be in violation of the laws that it administers and against which the Agency would initiate legal action, e.g., seizure. The FDA additionally emphasizes the “violation,” which is the main criterion to be applied in order to distinguish a recall from other actions. Under the current regulatory framework, a recall should take place in cases when a violation of applicable regulatory requirements is present. The purposes of a recall include notifying customers about the risks associated with the medical device in question and also removing the product from the market in order to make corrections necessary to ensure the safety of patients. 

The concept of recalls includes:

  • Voluntary recalls covered by 21 CFR part 7, subpart C either initiated by a firm on its own initiative or in response to a formal request from FDA, and
  • Mandatory recalls orders by FDA under section 518 of the [Food, Drug, and Cosmetic] FD&C Act and 21 CFR part 810.

In most cases, recalls are initiated by the entity responsible for a medical device in question (e.g., its manufacturer) and later monitored by the regulating authority. 

It is important to mention that the scope of the present guidance does not cover mandatory recalls initially initiated by the FDA. Additionally, cases when a new premarket submission is required or when radiation-emitting products fail to comply with the radiation safety requirements also fall outside the scope of the present guidance, together with methodologies for risk management and assessment. 

According to the document, a recall constitutes a mechanism allowing the medical device manufacturer to correct medical devices that fail to operate as intended and create a hazard to customers using them or to remove such devices from the market in order to ensure public health protection and safety of customers. In the course of a recall, the responsible entity shall identify the issue that creates ground for a recall, determine whether a recall is necessary, and commence the process. At the same time, in certain cases, it is difficult for the responsible entity to determine whether the grounds for a recall are present, as well as to outline the scope of a recall and notification timeline. The authority states that due to possible misinterpretation of the applicable regulatory requirements by the parties involved, there could be certain delays in notifying the stakeholders and conducting a recall itself. 

Moreover, responsible medical device manufacturers continuously improve their products and manufacturing processes and procedures associated thereto. Therefore, changes to the design occurring in the course of such improvements do not require a recall of medical devices already placed on the market by default. 

As it is stated by the FDA, the present guidance is intended to:

  • Clarify when a change to a device constitutes a medical device recall,
  • Distinguish those instances from device enhancements that do not meet the definition of a medical device recall, and 
  • Clarify reporting requirements under 21 CFR part 806. 

The regulating authority additionally emphasizes the importance of a correct categorization of the actions taken with regard to devices already placed on the market in order to determine the proper regulatory pathway to be followed. 

Key Definitions 

First, the present guidance provides the definitions of the most important terms and concepts used in the context of recalls, including the following: 

  • Correction – repair, modification, adjustment, relabelling, destruction, or inspection (including patient monitoring) of a device without its physical removal to some other location;
  • Device enhancement – a change to improve the performance or quality of a device that is not a change to remedy a violation of the FD&C Act or associated regulations enforced by the Agency. It is important to mention that the present definition is not provided in the applicable legislation but provided by the FDA for the purpose of this particular guidance. The authority also states that a device enhancement should not be treated as a recall. 
  • Stock recovery – 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 the control of, the firm and no portion of the lot has been released for sale or use. 

Apart from those listed above, the present guidance also provides the definitions of such terms as “market withdrawal,” “violation,” “removal,” “recall,” and “routine servicing.

Recall Identification 

The document further describes the particular approach to be applied by the medical device manufacturer in order to identify whether the planned action meets the definition of a recall and thus should be treated accordingly. The recommendations are provided in the form of questions and answers and cover the most important aspects associated with the recalls and corrections. 

In order to make a correct categorization, the medical device manufacturer shall consider the following:

  • The product in question should meet the definition of a medical device;
  • There should be planned change to a medical device;
  • A recall could be initiated only with regard to a medical device that has been already placed on the market and at the time of a recall is available for healthcare professionals and patients.

Differentiating Violative Devices from Non-Violative Devices 

As mentioned, a recall applies only when there is a certain violation of applicable regulations in place. If the medical device manufacturer decides to make changes to a product that is fully compliant with the applicable regulatory requirements, such action should be treated as a device enhancement and not as a recall due to the different grounds for the changes. Changes made in order to resolve the failure of a device to operate as intended are defined as recalls. The same applies in case of an increase in the overall failure rate of a medical device in question. 

In summary, the present document highlights the most important aspects related to the changes made to the medical devices already placed on the market. The guidance outlines the main differences between recalls and device enhancements conducted in order to improve the overall performance of a medical device that itself is fully compliant with the applicable legislation. 


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