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 remanufacturing medical devices and regulatory requirements associated thereto. Due to their legal nature, guidance documents issued by the FDA are initially intended to provide additional clarifications regarding the applicable legislation, as well as recommendations to be considered by medical device manufacturers and other parties involved to ensure compliance with the requirements set forth therein. Hence, the provisions of FDA guidance documents are non-binding. Moreover, an alternative approach could be applied, provided such an approach complies with the applicable regulatory requirements and has been agreed with the authority in advance.
Table of Contents
Among other aspects, the present FDA guidance outlines the particular criteria to be taken into consideration when determining whether the activity in question falls within the scope of remanufacturing activity. The document highlights the most important aspects and provides additional clarifications regarding the way they should be interpreted.
Significant Change
The first concept the FDA refers to is the concept of a significant change to device performance or safety specifications. According to the guidance, remanufacturing is the processing, conditioning, renovating, repackaging, restoring, or any other act done to a finished device that significantly changes the finished device’s performance or safety specifications, or intended use. In particular, the changes that will be considered significant are the ones that lead to a situation when a medical device subject to changes differs significantly from the specifications describing the initial device or results in additional risks arising. The document provides an example of changes to patient-contacting materials the device contains, that result in respective changes to the safety and performance of a medical device. In such a case, the appropriate process will be considered remanufacturing. At the same time, if in the course of the procedure one component of the device is being replaced by another component that is similar in terms of specifications, such replacement would not be considered remanufacturing.
The document also provides a list of activities the Agency considers the ones resulting in significant changes to a medical device already placed on the market. These changes include the following ones:
- Changes to the device’s sterilization methods;
- Changes to the device’s reprocessing instructions; and
- Changes to the device’s control mechanism, operating principle, or energy type.
Should any of the changes mentioned hereinabove take place, an additional evaluation will be no longer needed, as the activity will be considered remanufacturing.
The authority also mentions that significant changes to the intended use of a medical device are also considered as remanufacturing. Hence, any such changes should be subject to rigorous evaluation.
Determining Whether Activities are “Remanufacturing”: General Approach
In case the activities in question involve components, parts, or materials used for a medical device, the authority encourages the manufacturer to determine the regulatory status of such actions by applying a specific approach described in the guidance. The Agency additionally mentions that the general approach described herein should not be applied in the case of software due to specific aspects associated thereto. In such cases, a different approach should be applied.
To assist medical device manufacturers in determining whether the particular activity falls within the scope of “remanufacturing”, the Agency provides a flowchart describing the approach to be applied and the criteria to be taken into consideration. According to the flowchart, each change (e.gPhysical change or change to safety control) should first be assessed individually to determine whether the activity is likely to be remanufactured. In the case of numerous changes, their cumulative effect should be subject to evaluation as well. To evaluate the impact caused by the changes, a comparison to a medical device already placed on the market should be conducted. All the decisions taken should be justified and duly documented. The authority additionally emphasizes that the decision-making process itself should be documented as well. According to the guidance, the documentation should include:
- Product name (including model number and serial number, if applicable);
- Date of activities performed, assessment, and determination;
- Description of a device;
- Description of activities to be performed, including documentation of components/parts/materials involved;
- Determination of whether the activity is remanufacturing;
- Reference to related documents supporting the decision-making process; and
- Signature(s)
Criteria to be Considered
To assist medical device manufacturers in applying the aforementioned flowchart, the FDA also describes each criterion in detail.
- Add, remove, or change a component/part/material that directly or indirectly contacts body tissue?
- First of all, the manufacturer should assess the way the changes in question could affect existing reprocessing instructions. The authority additionally emphasizes the importance of safety-related matters in the context of patient-contacting materials. Moreover, special attention should be also paid to the materials used to manufacture the components used to transmit liquids and gases (the concept of indirect contact).
- Add or remove component/part/material or change the dimensional or performance specifications of a component/part/material?
- Once it is determined that certain changes to components and materials used took place, it is necessary to assess the significance of such changes in the context of safety and performance of a medical device in question in terms of the intended use. In particular, at this stage, the manufacturer shall assess the way the changes impact reprocessing of the device. For instance, in case such changes result in a situation when the modified device cannot withstand the appropriate number of reprocessing cycles as prescribed by the initial specification, this should be considered as a significant change.
- Is there a new or modified risk or is there a change in the performance of safety specifications?
- Under the risk-based approach, the manufacturer should also evaluate the changes to the risk profile of a medical device caused by the changes. According to the guidance, the changes should be assessed both separately and cumulatively. At this stage, the manufacturer shall identify the new risks arising (if any), as well as significance of deviations from the initial specifications.
In summary, the present FDA guidance describes the approach to be applied by medical device manufacturers when evaluating the changes to a medical device already placed on the market. The document highlights the most important aspects to be taken into consideration when determining the regulatory status of the changes made and also describes the assessment process step-by-step.
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