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or the Agency), the US regulating authority in the sphere of medical devices and other healthcare products, has issued draft guidance on remanufacturing of medical devices.
The document was published to commence public consultations and obtain feedback from industry representatives and other parties involved. The Agency will accept comments and suggestions within a period of sixty days from the date the appropriate notice has been published in the Federal Register. Once finalized, the guidance will provide additional recommendations and clarifications on the matter to be considered by the parties conducting operations with medical devices.
Due to their legal nature, FDA guidance documents do not introduce new requirements themselves but describe how current legislation should be interpreted and applied. 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.
Table of Contents
Regulatory Background
The Agency acknowledges that sometimes multiple-use medical devices require certain operations to be performed to ensure their use in a safe and efficient manner during the whole product lifecycle. This can include preventive maintenance and repair. At the same time, the authority states that there is no clear distinction between the concepts of “servicing” and “remanufacturing.” It is mentioned that remanufacturing has implications for the regulatory responsibilities of entities performing these activities. The present document describes in detail the concept of “remanufacturing” in terms of regulatory requirements to be followed. Additionally, the Agency provides recommendations related to the labeling of such products.
The document also contains references to the FDA-recognised voluntary consensus standards medical device manufacturers may refer to in order to demonstrate compliance with the applicable regulatory requirements.
As mentioned, from a regulatory standpoint, it is important to distinguish “servicing” and “remanufacturing.” According to the information available to the FDA, inadequate “servicing” could result in adverse events. The public discussion on the distinction between these two concepts was commenced by the regulating authority earlier in 2018 when the appropriate white paper was published.
Key Definitions
According to the present draft guidance, the two important concepts are defined in the following way:
- Remanufacturing – 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.
- Servicing – the repair and/or preventive or routine maintenance of one or more parts in a finished device, after distribution, for purpose of returning it to the safety and performance specifications established by the original equipment manufacturer (OEM) and to meet its original intended use.
Servicing of medical devices is subject to regulation by the FDA under the Federal Food, Drug, and Cosmetic (FD&C) Act. The Agency additionally emphasizes that irrespectively of whether the entity deems the operations conducted to be “servicing” or “remanufacturing,” it will assess the activities carried out in order to determine their regulatory status and legislation to be applied. It is stated that currently, the special regulations for remanufacturing are in the process of implementation. The new regulatory framework for remanufacturing of medical devices will cover such aspects as registration, listing, adverse event reporting, the Quality System (QS) regulation, and marketing submissions.
Apart from the ones described above, the document provides definitions of other important terms, such as:
- Repair stands for a type of servicing that returns a component to original specifications, including replacing non-working components or parts outside of routine or periodic upkeep for the current owner of the device.
- Reprocessing – validated process used to render a medical device, which has been previously used or contaminated, fit for a subsequent single use on a patient. In general, the purpose of such a process is to make the device available for further use.
Regulation on Remanufacturing in Detail
The present guidance is intended to provide additional clarity for the distinction between servicing and remanufacturing activities. In particular, the document is mostly focused on the operations related to remanufacturing. Such operations could be conducted with regard to medical devices intended to be reused and maintained. The Agency additionally emphasizes that the present guidance is not intended to amend the approach to such devices but to provide additional clarity for the parties involved. The authority mentions that the provisions of the draft guidance could be applied for any and all reusable medical devices irrespectively of their class under the risk-based classification. It is also stated that reprocessed single-use medical devices fall outside the scope of the present guidance.
The approach the Agency suggests to use for the purpose of determining whether the activity in question falls within the scope of remanufacturing is based on several important principles, namely:
- Assess whether there is a change to the intended use. Under the general rule, servicing is usually carried out in order to restore the device to its initial condition so that it could be further used for its intended purpose indicated by the manufacturer. In such a case, the device should be restored to the initial condition strictly in accordance with the safety and performance specifications. Should the intended purpose of the device change after the activities performed with regard to the device, such activities should be treated as remanufacturing.
- Determine whether the activities, individually and cumulatively, significantly change the safety or performance specifications of a finished device. According to the applicable regulations, remanufacturing should have such an impact, even if it is related to the improvement of a medical device. Thus, any changes should be subject to a rigorous evaluation in order to assess the actual impact they cause. In the case of numerous minor changes, their cumulative effect should be considered as well.
- Evaluate whether any changes to a device require a new marketing submission. Certain changes made to a medical device could require the submission of a new 510(k) premarket notification. This will depend on the significance of changes made and the impact they cause on the safety and performance of the device.
- Assess component/part/material dimensional and performance specifications. The assessment a medical device should be subject to will also include the assessment of changes to its specifications, as it could potentially impact the safety and performance. As mentioned, in certain cases, a new submission will be required.
- Employ a risk-based approach. In the course of such an assessment, a responsible entity shall employ a risk-based approach. It is stated that a risk-based assessment is based on the combination of multiple risk concepts that are important for managing the risks of medical devices. Risk estimation, risk acceptability, risk control, benefit/risk analysis, assessment of hazards and hazardous situations, and overall risk evaluation are all concepts that can be applied during these activities. The document also refers to ISO 14971 as the main standard to be considered in this regard.
- Adequately document decision-making. Each time making a determination addressed herein, a responsible entity shall duly document the justification for the decision taken.
In summary, the present FDA draft guidance describes the approach to be applied when determining whether the activities carried out with regard to a medical device fall within the scope of servicing or remanufacturing. Depending on such a determination, the appropriate regulatory framework should be applied.
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