The FDA published final guidance on the remanufacturing of medical devices on May 9, 2024. It adds a new section on regulatory requirements that clarifies remanufacturers are subject to investigations and inspections by the agency.
Jeff Shuren, head of the FDA’s Center for Devices and Radiological Health, addressed the potential benefits of clarifying the definitions of servicing and remanufacturing for organizations seeking to maintain devices. He stated, “This guidance offers crucial clarity in distinguishing remanufacturing processes and helps eliminate perceived obstacles in accessing device repair or maintenance, provided it doesn’t compromise safety, performance, or intended use.”
In 2021, the FDA released a draft guidance aiming to delineate between device servicing and remanufacturing. Many reusable medical devices undergo servicing, but the criteria for when servicing transitions into remanufacturing were previously ambiguous.
The draft defined remanufacturing as any action performed on a finished device that significantly alters its performance, safety, or intended use, encompassing activities like renovation, repackaging, or restoration.
The added new section, titled “Regulatory Requirements and Considerations for Remanufacturers,” offers an overview of the FDA’s medical device regulations. Covering areas such as market authorization and product safety criteria, it provides valuable insights familiar to manufacturers but less commonly known among companies remanufacturing medical devices.
Guiding Principles
The FDA provides guiding principles to determine whether activities constitute remanufacturing, which significantly alters a finished medical device’s performance, safety specifications, or intended use. These principles aim to ensure compliance with regulations and promote patient safety:
- Evaluate Intended Use Changes: Any alteration to the device’s intended use warrants scrutiny to determine if it constitutes remanufacturing.
- Assess Changes to Safety and Performance: Activities, individually and cumulatively, that significantly alter a device’s safety or performance specifications, including enhancements, may be considered remanufacturing.
- Consider Regulatory Requirements: Changes may necessitate new marketing submissions, depending on the risk-based classification of the device and relevant regulations.
- Evaluate Component Specifications: Comparing changes in dimensional and performance specifications to OEM standards informs whether an activity is remanufacturing.
- Adopt a Risk-Based Approach: Utilize risk management principles outlined in ISO 14971 to assess activities, identifying new risks or modifications to known risks that may significantly impact device performance or safety.
- Document Decision-Making: Maintain thorough documentation detailing the rationale behind determining whether an activity constitutes remanufacturing, referencing supporting data and previous determinations when applicable. Effective documentation aids in decision-making and regulatory compliance during inspections or inquiries.
How to Determine if Activities are Remanufacturing
Determining whether activities constitute remanufacturing involves a comprehensive evaluation based on various factors outlined by the FDA. Key considerations include assessing changes to device performance, safety specifications, and intended use. Remanufacturing encompasses a range of processes such as processing, conditioning, renovating, or repackaging, leading to significant alterations in a finished device’s performance or safety specifications. Activities resulting in changes that deviate from the original equipment manufacturer’s (OEM) specifications or introduce new risks are typically classified as remanufacturing. A critical aspect is identifying significant changes to device performance or safety specifications, often determined through verification, validation testing, or risk-based assessments. For instance, modifications impacting sterilization methods, reprocessing instructions, or control mechanisms are indicative of remanufacturing. Additionally, alterations to materials contacting the human body, changes to components, or dimensional specifications may warrant closer scrutiny. Entities must meticulously document their rationale for determining remanufacturing status, including details like product information, activities performed, and assessments conducted. Furthermore, considering whether added, removed, or changed components interact with body tissue is crucial. Any modifications in this regard should prompt a risk-based assessment to ascertain impacts on biocompatibility or reprocessing instructions. Evaluation extends to assessing new or modified risks and changes in performance or safety specifications. Activities like removing safety features or impacting regulatory compliance signal potential remanufacturing. Moreover, alterations affecting device conformity to standards or introducing safety hazards necessitate careful scrutiny.
Ultimately, entities must weigh each change’s significance against the legally marketed device’s specifications and intended use. Thorough documentation and adherence to FDA guidelines ensure transparent decision-making processes and regulatory compliance.
Regulatory Requirements of Remanufacturing Device
Establishment Registration and Medical Device Listing:
- Owners or operators of establishments involved in medical device activities must register annually with the FDA under 21 CFR part 807.
- Registration includes listing devices and associated activities.
- Remanufacturers must obtain their own device listing and establishment registration, separate from OEM listings.
Marketing Authorization:
- Device risk determines regulatory controls.
- Devices are classified into class I, II, and III with increasing regulatory controls.
- Remanufacturers must comply with premarket requirements for FDA authorization.
Medical Device Reporting and Electronic Product Reports:
- Mandatory reporting under 21 CFR part 803 for device-related adverse events and product problems.
- Remanufacturers must report adverse events and malfunctions.
- Reporting also required for corrections, removals, defects, and failures to comply.
Quality System:
- Remanufacturers must have a quality system under 21 CFR part 820, unless exempt.
Labeling:
- Labeling requirements under 21 CFR part 801, with additional requirements for specific device types.
- Remanufacturers responsible for modifying and validating labeling changes for significant device alterations.
Considerations for Labeling:
- OEMs encouraged to provide servicing instructions to maintain device performance and safety.
- Instructions should include key specifications, maintenance activities, troubleshooting steps, precautions, and software information.
Examples
FDA gives the following examples to demonstrate if the activity is considered as remanufacturing. For each device or software, it provides different scenarios. If you have similar device please email infoChinaMedDevice.com
- Replace door for infusion pump
- Replace rotor for peristaltic infusion pump
- Replace gradient coil for MR system
- Replace gradient coil for MR system (different design)
- Replace tubing for sample processor
- Replace heating chamber for water bath
- Sharpen stainless steel manual drill
- Replace lens and epoxy for endoscope
- Add adapter to endoscope
- Replace motor for powered wheelchair
- Replace pump for TMS coil cooling system (different coolant)
- Cannibalize applicator B to repair applicator A (different surface area)
- Add software patch for specular microscope
- Add remote control capability to device
- Transition from Windows to Linux OS for device
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