The new article describes in detail special considerations related to remanufacturing medical devices and the determination of the legal status of such activities.
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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 final guidance document dedicated to remanufacturing medical devices based on the relevant drafts published earlier in 2021. The document describes in detail the applicable regulatory requirements and also provides additional clarifications and recommendations to be taken into consideration by medical device manufacturers and other parties involved in order to ensure compliance.
It is also important to mention that FDA guidance documents are non-binding in their legal nature, nor are they intended to introduce new rules or impose new obligations. Moreover, an alternative approach could be applied, provided such an approach is in line with the existing legal framework and has been agreed with the authority in advance.
According to the guidance, remanufacturing of medical devices involves processes that significantly alter a device’s performance or safety specifications or its intended use. The present guidance provides a comprehensive framework for assessing whether specific activities performed on medical devices qualify as remanufacturing.
Significant Changes to Device Performance or Safety Specifications
According to the FDA, a significant change to a device’s performance or safety specifications is one that results in a finished device that deviates from the original equipment manufacturer’s (OEM’s) specifications or introduces new or significantly modifies existing risks. Such changes are typically identified through verification and validation testing and risk-based assessments.
For instance, changing a material that contacts the human body and impacts the OEM’s validated reprocessing instructions is considered a significant change, likely qualifying as remanufacturing. In contrast, replacing an internal capacitor with identical specifications is not likely to be considered remanufacturing.
Certain activities are generally considered by the FDA to significantly change a device’s performance or safety specifications:
- Changes to the device’s sterilization methods
- Changes to the device’s reprocessing instructions
- Changes to the device’s control mechanism, operating principle, or energy type
Determining Whether Activities are Remanufacturing
According to the guidance, entities must evaluate if their activities change the intended use of the device, as significant changes in intended use (e.g., converting a single-use device to reusable or changing its anatomical location of use) are likely remanufacturing.
For component-related activities, the FDA recommends using a flowchart provided in the guidance to determine if the activities are likely considered remanufacturing. While the definitions and principles in this document apply to software, the approach described herein should not be used for software changes (the guidance also contains a separate section dedicated to software-specific considerations).
The flowchart and accompanying text in this section are designed to guide entities in assessing when to further evaluate activities through testing or risk-based assessment, particularly after confirming there is no significant change in intended use. Each change should first be assessed individually and then cumulatively to determine the overall impact on the device.
For OEMs or authorized entities performing activities on devices, evaluation using the flowchart is not necessary if the activities return the device to its original specifications. Such evaluations must be documented through the OEM’s quality management system.
Documentation Requirements
The document also pays attention to documentation requirements to be followed by the parties involved.
In particular, the guidance states that entities must document the decision-making process and rationale when determining if an activity is remanufacturing. The documentation should be detailed enough for an FDA investigator or third party to understand.
Key elements to include are:
- Product name, model number, and serial number
- Date of activities, assessment, and determination
- Device description
- Detailed description of activities performed
- Determination of whether the activity is remanufacturing
- References to supporting documents
- Signatures
Specific Considerations
In order to assist the parties involved in determining the regulatory status of the actions taken with respect to a medical device in question, the authority outlines specific considerations to be taken into account.
- Changes to Components that Contact Body Tissue: Entities should assess how their activities affect validated reprocessing instructions or cause adverse biological responses due to device contact with human tissue. Both direct (physical contact) and indirect contact (fluids or gases passing through the device) should be considered. If there is any change in material type, formulation, or chemical composition that contacts body tissue, a risk-based assessment should determine if there is a significant change to biocompatibility or reprocessing instructions, potentially qualifying the activity as remanufacturing.
- Changes to Component Specifications: Adding or removing components or changing their dimensional or performance specifications can significantly impact a device’s performance or safety. Examples include altering the inner or outer diameter of a tube or modifying the architecture of printed circuit boards. Such changes must be evaluated for their impact on performance and safety specifications. If these changes exceed acceptable specifications or tolerances, they likely constitute remanufacturing.
- New or Modified Risks: A risk-based assessment should identify any new or modified risks or changes in performance or safety specifications. Cumulative changes must be considered to determine their collective impact. Significant changes that introduce new risks or significantly alter existing ones, such as removing or bypassing safety features, are likely to be considered remanufacturing.
Conclusion
In summary, the present FDA guidance provides a comprehensive overview of the regulatory approach to be followed by the parties responsible for medical devices when determining the regulatory status of actions potentially considered reprocessing in order to ensure compliance with the relevant requirements set forth under the existing legal framework. The document outlines specific aspects to be taken into consideration and provides additional clarifications.
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