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A Deeper Dive into FDA Draft Guidance on the Remanufacturing of Medical Devices

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In the medical device industry, there exists a longstanding divide between device manufacturers (i.e., those who design, manufacture, fabricate, or process a finished device) and the third-party entities that service the devices (i.e., those that maintain, restore, refurbish, or repair a finished device after it has been distributed, for purposes of returning the device to the safety and performance specifications established by the manufacturer and to meet its original intended use). The divide stems in part, from the way these entities are regulated by the U.S. Food & Drug Administration (“FDA”). Currently, medical device manufacturers are subject to substantially more regulation by the FDA than are the third parties that later service the devices. Over the past several years, the FDA has assessed whether they should regulate device servicers, but they have thus far declined to do so. However, on June 24, 2021, the FDA issued the draft guidance, “Remanufacturing of Medical Devices”, through which the FDA seeks to clarify whether activities performed on medical devices are considered “servicing” or “remanufacturing.” The FDA explained that the clarification is not intended to adopt significant policy changes or change the regulatory requirements applicable to remanufacturers but is instead “intended to help provide consistency and better understanding of applicable statutory and regulatory requirements.” The guidance also includes recommendations for information that should be included in labeling. Below is a summary of what is included in the draft guidance.

“Remanufacturing” v. “Servicing”

The draft guidance addresses whether activities performed by OEMs and third parties on devices that are intended to be reused and maintained are considered “remanufacturing.” The FDA defined “remanufacturing” as “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,” on the other hand, “is the repair and/or preventive or routine maintenance of one or more parts in a finished device, after distribution, for purposes of returning it to the safety and performance specifications established by the OEM and to meet its original intended use.” If an entity performs remanufacturing activities, they are subject to the regulatory requirements set forth in the FD&C Act (even if the entity self-identifies as a “servicer”).

In determining whether activities are remanufacturing, the FDA recommends applying the following principles:

1.         Assess whether there is a change to the device’s intended use. Changes to the intended use should be evaluated to determine whether the activity is remanufacturing.

2.         Determine whether the activities, individually and cumulatively, significantly change the safety or performance specifications of a finished device. If so, the activity may be considered remanufacturing.

3.         Evaluate whether any changes to a device require a new marketing submission

4.         Assess component/part/material dimensional and performance specifications. Deviations in component/part/material specifications from the manufacturer’s legally-marketed device could result in significant changes to the device’s performance or safety specifications.

5.         Employ a risk-based approach when assessing whether an activity is remanufacturing. When a risk-based assessment identifies new risks or significant modifications to known risks, the activity is likely remanufacturing.

6.         Adequately document decision-making when deciding whether an activity is remanufacturing or not.

“Significant change” to a device

As stated herein, “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.” The FDA considers a “significant change” to be one that “results in a finished device that is outside the OEM’s performance or safety specifications or introduces new risks or significantly modifies existing risks.” The FDA believes the following activities result in a “significant change” to a device’s performance or safety regulations, and are thus, remanufacturing:

  • 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. 

For activities involving components/parts/materials, the draft guidance includes a flowchart to help entities determine if their activities are likely remanufacturing.  Notably, the flowchart should not be applied to software, due to its nature and the methods used to evaluate changes to software, which are separately addressed by the draft guidance. Additionally, the FDA does not recommend evaluation with the flowchart when an activity is performed on behalf of the OEM and the activity returns the legally marketed device to its original performance, safety specifications, and intended use, which would likely not be remanufacturing.  

The FDA recommends that when deciding whether an activity is remanufacturing, the entity should document its decision-making process and the basis for the determination. The documentation should include the following:

  • Product name (including model number and serial number, if applicable);
  • Date of activities performed, assessment, and determination;
  • Description of device;
  • Description of activities to be performed, including documentation of components/parts/materials involved;
  • Determination of whether the activity is remanufacturing (the FDA recommends using the applicable sections of its draft guidance);
  • Reference to related documents supporting the decision-making process; and
  • Signature(s).

Changes involving software

The FDA’s draft guidance notes that many software changes are likely remanufacturing, due to their impact on a product’s software architecture, software requirements specifications, and other key characteristics. As stated herein, the FDA says the above-mentioned risk-based assessment should not be applied to software changes. Instead, the FDA identified certain activities performed on software that are likely not remanufacturing because generally, the following activities do not significantly change the device’s performance or safety specifications:

  • 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 FDA notes that other activities involving changes to software are probably going to significantly change a device’s performance or safety specifications, thereby rending the activity remanufacturing.

Labeling considerations

The FDA said it is important that OEMs of reusable devices include instructions on how to adequately return a device to its performance and safety specifications. Otherwise, unintentional remanufacturing may occur. The FDA thus encouraged OEMs to provide servicing instructions to facilitate routine maintenance and repair of their reusable devices. The labeling should include the following information, as applicable:

  • A description of the key performance and safety specifications;
  • Critical technical or functional specifications, including:
    • Physical dimensions;
    • Electrical characteristics, including batteries (e.g., chemistry, amperage, voltage, rechargeability), internal fuses, and power supply (e.g., voltage, amperage, frequency); and
    • Device-specific performance specifications (e.g., flow rate accuracy or range, humidity, temperature, wavelength).
  • 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
  • Version number and release date of software.

Final guidance The draft guidance was issued on June 24, 2021 for comment purposes only. The comment period went through September 22, 2021. Once finalized, the guidance will represent the current thinking of the FDA on the topic of the remanufacturing of medical devices. As of this writing, the FDA has not yet finalized the guidance.