The article highlights the key points related to the regulatory framework for remanufacturing medical devices, outlining the main considerations and critical aspects.
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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, and are not 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.
Regulatory Background
First of all, the authority mentions that medical devices encompass a diverse range of products, each with unique technologies, lifecycles, complexities, intended users, and usage environments. Many of these devices are reusable, necessitating preventive maintenance and repair throughout their operational lives.
Proper servicing is crucial for maintaining the safe and effective use of these devices. However, there is often confusion between “servicing” and “remanufacturing”.
The distinction is significant because remanufacturing carries different regulatory responsibilities for the entities involved. This guidance is intended to clarify whether specific activities performed on devices qualify as “remanufacturing”, triggering respective requirements to be fulfilled by the parties involved.
It seeks to provide consistency and a better understanding of relevant statutory and regulatory requirements such products would be subject to. Additionally, it offers recommendations for labeling to ensure the continued quality, safety, and effectiveness of serviced devices.
The FDA has developed this guidance by considering objective evidence and insights from various agency activities. The document also contains references to the FDA-recognized voluntary consensus standards medical device manufacturers can use to demonstrate compliance with the relevant regulatory requirements.
More information on the use of consensus standards in regulatory submissions can be found in the FDA guidance documents “Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices” and “Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research”.
As it was mentioned before, in this guidance, the FDA has actively sought to clarify the distinction between “servicing” and “remanufacturing”. Efforts have included opening a docket for public comment and hosting a public workshop in 2016.
The FDA received numerous comments, complaints, and adverse event reports alleging inadequate servicing, which were analyzed and summarized in the FDA Report on Device Servicing, published later in May 2018. This report, mandated by section 710 of the FDA Reauthorization Act of 2017, concluded that many of the issues attributed to inadequate servicing were, in fact, related to remanufacturing.
In 2018, the FDA released a white paper, opened a public docket, and held a public workshop to further discuss the distinction between servicing and remanufacturing. The white paper outlined guiding principles, provided a flowchart for understanding the distinctions, and included considerations for software and labeling.
Feedback from these activities informed the development of this guidance. The distinction between “remanufacturing” and “servicing” is crucial. Remanufacturing involves processes that significantly change a device’s performance, safety specifications, or intended use. Servicing, on the other hand, refers to repairs and maintenance activities that restore a device to its original specifications without significantly altering its performance or safety.
The FDA’s authority to regulate the servicing of medical devices is based on its mandate under the Federal Food, Drug, and Cosmetic (FD&C) Act. Regardless of an entity’s designation as a “servicer” or “remanufacturer,” the FDA focuses on the specific activities performed on a device. The determination of whether these activities constitute remanufacturing affects the regulatory requirements and enforcement actions under the FD&C Act and the level of regulatory scrutiny such products will be subject to.
Scope
Given the confusion between servicing and remanufacturing, the FDA committed to providing guidance to clarify these activities. This document focuses on activities likely to be considered remanufacturing. It addresses activities performed on reusable and maintainable devices by both OEMs and third parties.
The guidance does not introduce significant policy changes but aims to clarify existing definitions and regulatory requirements. This guidance applies to devices as defined in section 201(h) of the FD&C Act, including software and electronic products that meet the device definition.
The concepts discussed are relevant to all reusable devices, regardless of their classification (Class I, II, or III), including those requiring premarket approval. However, this guidance does not cover reprocessed single-use devices.
Definitions
In order to assist the parties involved with interpreting the relevant legal provisions and following the regulatory requirements set forth therein, the document provides definitions of the key terms and concepts used in the context of remanufacturing medical devices including, inter alia, the following ones:
- Intended Use: The general purpose or function of the device, encompassing the indications for use.
- Manufacturers (OEMs or Remanufacturers): Entities that design, manufacture, fabricate, assemble, or process a finished device. A remanufacturer significantly changes a device’s performance or safety specifications or intended use.
- Performance Specifications: Characteristics established by the OEM for the device to perform as intended, including measurement accuracy, output accuracy, and stability criteria.
- Recondition/Refurbish/Rebuild: Activities that restore a device to the OEM’s original specifications comparable to when new, without significantly altering performance or safety specifications.
- Remanufacture: Processes that significantly change a device’s performance or safety specifications or intended use.
- Repair: A type of servicing that returns a component to the OEM’s original specifications, including the replacement of non-working components or parts outside of preventive maintenance.
- Reprocess: Validated processes to render a used or contaminated device fit for subsequent use by removing contaminants and inactivating microorganisms.
- Safety Specifications: Safety characteristics established by the OEM for the safe use of the device, including alarms, sensors, and fail-safe mechanisms.
- Service: Repair and preventive maintenance activities that restore a device to the OEM’s original specifications without significantly altering its performance or safety.
- Third-Party Servicers and Independent Service Organizations (ISOs): Entities other than the OEM or healthcare delivery organizations that service a finished device to return it to the OEM’s original specifications.
Guiding Principles
The document further outlines the key guiding principles that help to determine whether activities are remanufacturing:
- Assess Changes to Intended Use: Evaluate whether any changes alter the device’s intended use. Servicing should restore the device to its original specifications and intended use.
- Significant Changes to Safety or Performance: Determine if activities significantly change the device’s safety or performance specifications. Even enhancements should be evaluated for their impact on the device’s original specifications.
- New Marketing Submissions: Assess if changes require a new marketing submission, such as a premarket notification (510(k)), premarket approval application, or other submissions as per the FD&C Act.
- Component/Part/Material Specifications: Evaluate changes to component specifications to determine their impact on the device’s performance or safety.
- Risk-Based Approach: Use a risk-based approach, consistent with ISO 14971, to assess whether activities constitute remanufacturing. This includes evaluating new risks or significant modifications to known risks.
- Documentation of Decision-Making: Adequately document the rationale for determining whether an activity is remanufacturing. Include supporting verification and validation data to justify decisions, facilitating sound decision-making and regulatory compliance.
The above principles should be used to determine the regulatory status of the actions taken with respect to a medical device in order to ensure the appropriate approach is followed.
Conclusion
In summary, the present guidance provides a general background pertaining to the regulatory concepts of “servicing” and “remanufacturing” medical devices, highlighting the main differences and similarities. The document also explains the position of the authority and outlines the recommended approach to be followed to ensure the proper determination of the legal nature of such actions.
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