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 regulatory matters associated with remanufacturing medical devices. The document is intended to provide non-binding clarifications and recommendations to be taken into consideration by medical device manufacturers and other parties involved to ensure compliance with the applicable regulatory requirements. The Agency also states that an alternative approach could be also applied, provided such an approach complies with existing legislation and has been agreed with the regulating authority in advance.
Changes Involving Software
According to the guidance, various changes to the device could be considered as remanufacturing since they result in significant changes to the software infrastructure of a medical device in question, the appropriate software requirements specifications, and other important aspects. Moreover, the FDA emphasizes that usual methods could hardly be applied when identifying potential software failures due to the specific nature of software and malfunctions associated thereto. To assist medical device manufacturers (software developers) in determining the regulatory status of changes to the software, the Agency outlines the scope of activities that are likely not remanufacturing due to the nature of changes associated thereto. These activities include, inter alia, the following ones:
- Activities performed on behalf of or otherwise explicitly authorized by the OEM that return the legally marketed device to its performance and safety specifications, and intended use;
- Implementing OEM provided updates and upgrades;
- Running software-based hardware diagnostics;
- Assessing for viruses, malware, and other cybersecurity-related issues;
- Reinstalling OEM software to restore original performance and safety specifications;
- Reverting software to a previous configuration;
- Installing cybersecurity updates that are authorized by the OEM;
- Turning on or off connectivity features (e.g., Wi-Fi and Bluetooth connections) consistent with OEM intended use;
- Performing data backup and recovery operations;
- Assessing software inventory;
- Collecting system logs;
- Managing user accounts; and
- Accessing diagnostic and repair information.
The activities falling beyond the scope outlined hereinabove are more likely to result in significant changes to the safety and performance of a medical device. Hence, such activities would be deemed as remanufacturing and should be treated accordingly. At the same time, if the entity has a reasonable belief that the activity in question is not remanufacturing, the decision-making process should be duly documented. Additionally, the Agency states that any activity resulting in significant changes to the intended use of a medical device is remanufacturing. The regulating authority also emphasizes that the responsible entity should take into consideration such factors as unintended consequences, as well as the cumulative effect of modifications the software is subject to. According to the guidance, the changes should be assessed both separately and in connection with each other to ensure a comprehensive evaluation of the impact caused to the safety and performance characteristics of a medical device. In case of any decisions taken, the reasons for such decisions should be duly documented.
Considerations for Labeling
As described by the FDA, reusable medical devices are initially designed in a way ensuring they will remain operational after numerous cycles of preventive maintenance and repair. In particular, such devices are supplied with the appropriate instructions describing the steps to be taken by a user to return it to the initial specifications as determined by the manufacturer. At the same time, in case of such actions taken without having necessary instructions in place could result in unintentional remanufacturing. According to the guidance, this could result in unexpected changes to the safety and performance of the device. Thus, to ensure continuous safety and effectiveness of reusable medical devices, the Agency encourages the manufacturers to supply their products accompanied with detailed enough instructions describing the particular procedures to be performed in the course of routine maintenance and repair. In this context, the labeling for such devices should contain such details as:
- A description of the key performance and safety specifications;
- Critical technical or functional specifications, including:
- Physical dimensions;
- Electrical characteristics; and
- Device-specific performance specifications.
- The recommended maintenance activities and schedule;
- Recommended routine testing and acceptance criteria to confirm that the device remains within its performance and safety specifications;
- A description of error codes, alerts, and alarm features on the device;
- Precautions and warnings relevant to servicing the device; and
- The version number and release date of the software.
Additional notes also remind that according to the general requirements, the labeling should contain detailed enough directions for use. If the product in question is a non-prescription device, the directions should also describe the way the device should be prepared for use, while this requirement does not apply for prescription devices.
Apart from specific aspects described hereinabove, the guidance also provides several examples of activities medical devices could be subject to and describes the way such activities should be treated by the parties involved by the applicable regulatory requirements. In particular, the document provides examples of activities that are not considered remanufacturing and also explains the reason behind such an approach. At the same time, the Agency additionally emphasizes that these are simplified examples intended to demonstrate the way the regulatory requirements could be applied, but they should not be used instead of device-specific legal advice. When making a similar determination in a real situation, numerous factors should be considered. All examples are divided into several groups depending on the main factors including, inter alia, the following ones:
- Component/part/material activities. In the first example, an element that is not in contact with the patient’s skin is being replaced with a similar element produced by a different manufacturer. Since such a replacement does not significantly affect the safety and performance specifications of the device, it would not be considered remanufacturing.
- Software activities. In one of the examples related to software changes, the FDA describes a situation when a remote control capacity is added to allow healthcare professionals to impact the operations of the device remotely. Since such changes result in new risks and functionally impact significantly the safety and performance specifications of the device, these changes would be deemed remanufacturing.
In summary, the present FDA guidance covers the most important aspects related to remanufacturing medical devices and regulatory procedures associated thereto. The document outlines the main factors to be considered when determining the regulatory status of changes to a medical device to evaluate the impact caused by such changes to the safety and performance specifications of the device.
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