Remanufacturing of Medical Devices
Published: 2024-05-09
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Remanufacturing of Medical Devices
Published: 2024-05-09
This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff or Office responsible for this guidance as listed on the title page.
I. Introduction
Medical devices encompass a vast array of products with different technologies, product lifecycles, complexity, intended users, and environments of use. Many devices are reusable and need preventive maintenance and repair during their useful life. For these devices, proper servicing is critical to their continued safe and effective use. However, there is a lack of clarity regarding the distinction between “servicing” and “remanufacturing” of a device. Most notably, remanufacturing has implications for the regulatory responsibilities of entities performing these activities.1
This guidance is intended to help clarify whether activities performed on devices are likely “remanufacturing.” Such clarification is intended to help provide consistency and better understanding of applicable statutory and regulatory requirements. This guidance also includes recommendations for information that should be included in labeling to help assure the continued quality, safety, and effectiveness of devices that are intended to be serviced over their useful life. In developing this guidance, FDA considered objective evidence and information learned from the Agency’s activities discussed in this guidance.
For the current edition of the FDA-recognized standard(s) referenced in this document, see the FDA Recognized Consensus Standards Database.2 For more information regarding use of consensus standards in regulatory submissions, please refer to the FDA guidance titled
1 FDA’s Report on the Quality, Safety, and Effectiveness of Servicing of Medical Devices (FDA Report on Device Servicing) discusses medical device servicing in more detail, available at https://www.fda.gov/media/ 113431/download. 2 Available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm.
VIII. Regulatory Requirements and Considerations for
Remanufacturers As stated above, remanufacturers47 are considered manufacturers under the FD&C Act and FDA’s regulations,48 and are thus regulated as such. Entities that are remanufacturing devices, including devices that they did not originally manufacture, are generally subject to the same regulatory requirements as the OEM of the device. Basic regulatory requirements (general controls) that manufacturers of medical devices distributed in the U.S. must comply with, unless exempted by regulations, include, but are not limited to: Establishment Registration and Medical Device Listing (21 CFR part 807), Medical Device Reporting and Notification (21 CFR parts 803, and 1002) requirements, Recalls and Reports of Corrections and Removals (21 CFR parts 7, 806, 810, and 1003), Quality System (QS) Regulation (21 CFR part 820), and Labeling requirements (21 CFR parts 801, 809, 830, and 1010).49, 50 Many device types also require premarket review, including premarket notification (also known as 510(k)) (21 CFR part 807) or premarket approval (PMA) (21 CFR part 814), depending on their device classification and other factors. Certain devices have additional regulatory requirements such as compliance with special controls, which are usually specific to devices for which general controls alone are insufficient to provide reasonable assurance of the safety and effectiveness of the device.51 Unique considerations for remanufacturers for complying with these regulatory requirements are described below.
Registered remanufacturers and entities engaged in remanufacturing are subject to investigations and inspections to ensure compliance with the FD&C Act.52 In planning and conducting inspections of medical device facilities, the Agency considers risk-based factors consistent with the FD&C Act to allocate resources effectively to carry out the Agency’s mission of protecting and promoting public health.53 When a medical device manufacturer, including a remanufacturer, fails to comply with the FD&C Act and its implementing regulations, FDA has the authority to respond with enforcement tools. In most cases, the manufacturer will take voluntary action to correct any violations identified by FDA to avoid the need for enforcement actions.
47 The considerations in this section apply to OEMs, third party servicers, and ISOs. The intent of this section is to provide additional insights for entities that may be less familiar with the FDA’s medical device regulatory requirements. 48 E.g., 21 CFR 820.3(o) and 21 CFR 820.3(w). 49 For additional information regarding basic regulatory requirements for device manufacturers, see FDA’s website, “Overview of Device Regulation,” available at https://www.fda.gov/medical-devices/device-advice-comprehensiveregulatory-assistance/overview-device-regulation. 50 For additional information regarding regulations and requirements specific to radiation-emitting devices, see FDA’s website, “Radiation-Emitting Products,” available at https://www.fda.gov/radiation-emitting-products. 51 For additional information regarding Special Controls and Premarket Approval for device manufacturers, see FDA’s website, “Regulatory Controls” available at https://www.fda.gov/medical-devices/overview-deviceregulation/regulatory-controls. Establishment Registration and Medical Device Listing Under 21 CFR part 807, owners or operators of establishments that are involved in the manufacture, preparation, propagation, compounding, assembly, or processing of medical devices intended for human use in the U.S. are generally required to register annually with FDA. Generally, establishments that are required to register with FDA are also required to list their devices and the activities that are performed on those devices. As manufacturers, remanufacturers of medical devices54 are also required to obtain their own device listing, independent of OEM’s device listing, and their own establishment registration if not already registered as a device manufacturer.55
Marketing Authorization The risk of the device determines the regulatory controls needed to provide a reasonable assurance of safety and effectiveness. Medical devices are classified into class I, II, and III with increasing regulatory controls. The class to which a device is assigned determines, among other things, the type of premarket submission or application that is required for FDA authorization to market. Most class I devices, which includes devices with the lowest risk, are exempt from premarket notification (i.e., 510(k) Exempt); class II devices require premarket notification (i.e., a 510(k)) unless exempt by regulation; and class III devices (those that are the highest risk) require premarket approval (i.e., a PMA). Remanufacturers are responsible for complying with premarket requirements, including obtaining the required FDA marketing authorization prior to conducting remanufacturing activities on the OEM’s legally marketed finished device.56 The relevant regulatory standard must be met for remanufactured devices, which have experienced a significant change to performance or safety specifications, or intended use, as compared to the OEM’s legally marketed finished device. For example, for remanufactured devices requiring a 510(k), the remanufacturer must demonstrate that the device is “substantially equivalent” to a legally marketed predicate device in terms of intended use, technological characteristics, and performance testing, as needed. For remanufactured devices requiring a PMA, the remanufacturer must provide valid scientific evidence demonstrating a reasonable assurance of safety and effectiveness for the device’s intended use.
54 As noted in Section II of this guidance, FDA focuses on the specific activities an entity performs on a particular device when determining whether an entity is the remanufacturer of the device and not on the entity’s self-identified designation. 55 For additional information on who must, when to, and how to register and list, see FDA’s website “Device Registration and listing,” available at https://www.fda.gov/medical-devices/how-study-and-market-yourdevice/device-registration-and-listing 56 Remanufactured devices may require different regulatory controls from the OEM’s legally marketed finished device to provide a reasonable assurance of safety and effectiveness. Remanufacturers must identify the correct classification for the device to understand and comply with the applicable regulatory controls. For additional information on premarket submissions, see FDA’s website “How to Study and Market Your Device,” available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/how-study-and-marketyour-device. Medical Device Reporting and Electronic Product Reports The Medical Device Reporting (MDR) regulation (21 CFR part 803) contains mandatory requirements for manufacturers, distributors, importers, and device user facilities to report certain device-related adverse events and product problems to FDA. 21 CFR part 1002 sets forth the requirements for records and reports that must be kept and submitted for certain electronic products. Manufacturers, including remanufacturers, are required to report to FDA when they learn that any of their devices may have caused or contributed to a death or serious injury.57 Manufacturers must also report to FDA when they become aware that their device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.58 As manufacturers, remanufacturers also are responsible for reporting adverse events and certain malfunctions, as further defined and outlined in 21 CFR parts 803 and 1002, regarding their remanufactured device to FDA.
Reports of Corrections and Removals and Notifications of Defects Under 21 CFR part 806, Medical Device Reports of Correction and Removals, manufacturers and importers are required to submit a written report to FDA of any correction or removal of medical devices if the correction or removal was initiated to reduce a risk to health posed by the device or to remedy a violation of the FD&C Act caused by the device which may present a risk to health.59 Even if a remanufacturer is not required to report a correction or removal of a device to FDA under 21 CFR 806.10, records of such actions must be kept.60 Under 21 CFR part 1003, Notification of Defects or Failure to Comply, manufacturers, assemblers, and importers of electronic products who discover a defect or that the product otherwise fails to comply with applicable standards, are required to submit written notification to the FDA, and when applicable, affected persons.61
Firms may also choose to voluntarily report under 21 CFR part 7 if it conducts a recall, which is a firm's removal or correction of a marketed product that FDA considers to be in violation of the laws it administers and against which the agency would initiate legal action, e.g., seizure.62 A recall may be undertaken voluntarily and at any time by manufacturers and distributors, or at the
Electronic Products. Device Recall Authority.64 As manufacturers, remanufacturers are responsible for taking action and reporting to FDA any correction or removal which was initiated to reduce a risk to health posed by the device or to remedy a violation of the Act caused by the device which may present a risk to health.
Quality System The QS Regulation (21 CFR part 820) includes requirements related to the methods used in and the facilities and controls used for: designing, purchasing, manufacturing, packaging, labeling, storing, installing and servicing of medical devices.65 Remanufacturers of medical devices are required to have a quality system in place for their device, unless the device is exempt from good manufacturing practices (GMP) requirements.66
Labeling Labeling includes labels on the device as well as descriptive and informational literature that accompanies the device.67 General device labeling requirements are found in 21 CFR part 801. Additional labeling requirements for in vitro diagnostics (IVDs) are found in 21 CFR part 809 and labeling requirements for electronic products are found in 21 CFR part 1010. Unique device identification (UDI) labeling requirements are found in 21 CFR part 830.68 Remanufactured devices most likely already have labeling associated with them that is provided by the OEM of the finished device. Remanufacturing activities that significantly change the performance or safety specifications of a device, or its intended use, are likely to require corresponding labeling changes. For example, if a remanufacturer adds a feature or function to a reusable device, such modification would necessitate labeling changes to provide adequate instructions for how to use the new feature or function and to the associated reprocessing instructions to ensure the device
63 For additional information on medical device recalls and corrections and removals, see FDA’s website “Recalls, Corrections and Removals (Devices),” available at https://www.fda.gov/medical-devices/postmarket-requirementsdevices/recalls-corrections-and-removals-devices. 65 For additional information and resources on the Quality System regulation, see FDA’s website “Quality System (QS) Regulation/Medical Device Good Manufacturing Practices,” available at https://www.fda.gov/medicaldevices/postmarket-requirements-devices/quality-system-qs-regulationmedical-device-good-manufacturingpractices. Exemption from the GMP requirements does not exempt manufacturers of finished devices from keeping complaint files (21 CFR 820.198) or from general requirements concerning records (21 CFR 820.180). 68 For additional information on the UDI System including the Global Unique Device Identification Database (GUDID) submission requirements, see FDA’s website “Unique Device Identification System (UDI System),” available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/uniquedevice-identification-system-udi-system. can be reused safely and effectively with the new feature or function. It is the responsibility of the remanufacturer to modify and validate any necessary labeling changes that are associated with the specific remanufacturing activity including, but not limited to, the remanufacturer identifying information, obtaining a new UDI, and modifying directions for use, device specifications, and warnings as needed.69
IX. Considerations for Labeling
Based on publicly available information and FDA’s activities discussed in Section II of this guidance, FDA believes that OEMs of reusable devices intend for their devices to routinely undergo both preventive maintenance and repair. It is important that such devices include instructions on how to adequately return a device to its performance and safety specifications established by the OEM.70 Unintentional remanufacturing can occur when entities do not have the instructions necessary to return a device to its original performance and safety specifications. The lack of adequate servicing instructions can also create challenges in the availability of quality, safe, and effective devices.
Consistent with promoting and protecting the public health, FDA encourages OEMs, as an industry best practice, to provide servicing instructions that facilitate routine maintenance and repair of their reusable devices. FDA’s recommendations are not intended to encourage the disclosure of trade secrets or confidential commercial information. The OEM labeling of reusable devices should include at least the following information, as applicable, to facilitate routine device maintenance and repair: • A description of the key performance and safety specifications; • Critical technical or functional specifications, including: o Physical dimensions; o Electrical characteristics, including batteries (e.g., chemistry, amperage, voltage, rechargeability), internal fuses, and power supply (e.g., voltage, amperage, frequency); and o Device-specific performance specifications (e.g., flow rate accuracy or range, humidity, temperature, wavelength). • The recommended maintenance activities and schedule; • Recommended troubleshooting steps, 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;
Prescription devices are exempt from the adequate directions for use requirement provided certain conditions are met, including that the labeling bear “information for use, including indications, effects, routes, methods, and frequency and duration of administration, and any relevant hazards, contraindications, side effects, and precautions under which practitioners licensed by law to administer the device can use the device safely and for the purpose for which it is intended…” 21 CFR 801.109(c). • Precautions, and warnings relevant to servicing the device; and • Version number and release date of software. Appendix A. Examples The following are illustrative examples of activities that may be performed on devices with explanations about why such examples are or are not likely remanufacturing. Note that these generalized examples do not necessarily account for every possible detail, risk, or consideration that an entity should evaluate, and should not be taken to mean that the changes described are or are not definitively remanufacturing. Real-world decisions will depend on the specific facts and circumstances, including the specific details of the changes made to the specific device. FDA recommends referencing the guiding principles when considering the examples to expand understanding. For example, when reviewing the activities outlined in the examples below, it may be helpful to consider whether the activity results in changes to a device that would require a new marketing submission (consistent with Guiding Principle 3) and how a risk-based approach, such as ISO 14971: Medical devices – Application of risk management to medical devices may be instrumental in assessing risk (consistent with Guiding Principle 5).
(1) Component/part/material activities Example E.1 Activity: The door of an infusion pump was bent and now pinches the administration set. The flow rate accuracy fell outside the OEM’s specified accuracy range. The door is replaced with a non-OEM door that is marketed as compatible with this infusion pump. It has the same overall dimensions and is made from a similar material of construction. However, the replacement door material is more rigid than the original door.
Relevant questions: A1. Add, remove, or change a component/part/material that directly or indirectly contacts body tissue? No. The existing and replacement doors do not have direct or indirect contact with the patient’s body tissue.
A2. Add or remove component/part/material or change the dimensional or performance specifications of a component/part/material? Yes, the old door was removed and replaced. While the new door is marketed as compatible, all dimensions were confirmed through comparative measurement, including the hinges and latch. The specific material of the original door is unknown and there is a noticeable difference in flexibility that may impact the pump’s performance specifications.
A2.1 Is there a significant change to device performance or safety specifications? No. Once replaced, the door was confirmed to open and close with similar effort as the original door and it was confirmed that the added rigidity did not significantly change the pump’s performance or safety specifications (e.g., flowrate accuracy). A3. Is there a new or modified risk or is there a change in the performance or safety specifications? No. A risk-based assessment determined that there are no new or modified risks and there is no change in performance or safety specifications (e.g., the change does not alter conformity to a voluntary consensus standard or compliance with a regulation).
Decision: Not Remanufacturing.
Example E.2 Activity: The rotor within a peristaltic infusion pump no longer functions as intended and is replaced. The subject pump rotor is no longer supported by the OEM, but a comparable offthe-shelf rotor is available. The dimensions of the rotor, including the individual rollers, are the same; however, the material of construction of the rollers, which contact and apply pressure to the administration set, appears to be stainless steel. This is different from the plastic rollers in the legally marketed device.
Relevant questions: A1. Add, remove, or change a component/part/material that directly or indirectly contacts body tissue? No. Neither the existing or replacement component directly or indirectly contact body tissue. It is only in contact with the outside of the administration set.
A2. Add or remove component/part/material or change the dimensional or performance specifications of a component/part/material? Yes. The rotor was removed and replaced. Also, although the dimensional specifications of the non-OEM pump rotor, including the individual rollers, are the same as the OEM rotor, the roller materials are different.
A2.1 Is there a significant change to device performance or safety specifications? Yes. Once the rotor was replaced, the device appears to function adequately. The change in material of the rollers does not significantly change the accuracy of the flowrate across the labeled flowrate range. However, a risk-based assessment identified that the change in material of the rollers can affect the useful life of the administration set. The change in the roller material from plastic to stainless steel increases the administration set wear and/or breakage due to fatigue. Evaluation of this risk concluded that the increased fatigue on the administration set is more likely to lead to patient under-dosing before the administration set is intended to be replaced. This significantly changes the device’s performance and safety specifications.
Decision: Remanufacturing.
Example E.3 Activity: The gradient coil of a magnetic resonance (MR) system was damaged during an imaging session and needs to be replaced. The gradient coil is replaced with a non-OEM gradient coil. The maximum slew rate of the coil matches that of the OEM gradient coil; however, the peak gradient strength is larger than the OEM coil. Relevant questions: A1. Add, remove, or change a component/part/material that directly or indirectly contacts body tissue? No. The gradient coil does not have direct or indirect contact with body tissue.
A2. Add or remove component/part/material or change the dimensional or performance specifications of a component/part/material? Yes. The gradient coil was removed and replaced, and the new gradient coil has a larger peak gradient strength.
A2.1 Is there a significant change to device performance or safety specifications? Yes. An assessment was performed to determine the significance of the change. A gradient coil with a larger peak gradient strength significantly changes the imaging performance specifications (e.g., slice thickness, spatial resolution).
Decision: Remanufacturing.
Activity: The gradient coil of an MR system was damaged during an imaging session and needs to be replaced. It is replaced with a non-OEM gradient coil that has different dimensional specifications and coil design.
Relevant questions: In this example, the answers to flowchart questions A1 and A2 are the same as Example E.3.a. except that for A2, the new gradient coil has different dimensional specifications and coil design.
A2.1 Is there a significant change to device performance or safety specifications? No. The new gradient coil only differs by small changes in design and dimensional specifications. There are no significant changes to the performance and safety specifications (e.g., slew rate, peak gradient strength, power).
A3. Is there a new or modified risk or is there a change in the performance or safety specifications? No. A risk-based assessment identified no new or modified risks or change in the performance or safety specifications due to this change because the non-OEM gradient coil has the same hardware performance specifications (e.g., slew rate), equivalent imaging performance, and meets the same safety and performance specifications (e.g., acoustic output) when compared to the OEM gradient coil.
Decision: Not Remanufacturing.
Example E.4 Activity: The slide heater pads on an immunohistochemistry (IHC) autostainer are worn out and need to be replaced. They are replaced with an OEM part. Relevant questions: A1. Add, remove, or change a component/part/material that directly or indirectly contacts body tissue? No. The slide heater pads do not have direct or indirect contact with body tissue.
A2. Add or remove component/part/material or change the dimensional or performance specifications of a component/part/material? Yes. The heater pad components were physically removed and replaced with new pads.
A2.1 Is there a significant change to device performance or safety specifications? No. An assessment was performed to evaluate this replacement and identified no changes to dimensions, materials, or performance or safety specifications of the pads.
A3. Is there a new or modified risk or is there a change in the performance or safety specifications? No. A risk-based assessment identified no new or modified risks because the slide heater pads are identical to the original part from the OEM. The device now functions within its functional specifications identified in the labeling. There is no change in the performance or safety specifications.
Decision: Not Remanufacturing.
Example E.5 Activity: The tubing on a sample processor became kinked from use and needs to be replaced. Tubing was found from the same OEM, but the tubing is intended for use with a different sample processor.
Relevant questions: A1. Add, remove, or change a component/part/material that directly or indirectly contacts body tissue? No. There is no direct or indirect contact between the tubing and body tissue.
A2. Add or remove component/part/material or change the dimensional or performance specifications of a component/part/material? Yes. The tubing was removed and replaced with new tubing of a different inner diameter.
A2.1 Is there a significant change to device performance or safety specifications? Yes. The inner diameter of the tubing is different from the legally marketed device. Verification and validation testing was performed to evaluate this replacement and identified significant changes to performance because different fluid characteristics (e.g., flow rate) than those specified for the legally marketed device were noted with the new tubing.
Decision: Remanufacturing.
Example E.6 Activity: A tissue pre-treatment water bath was updated by replacing the heating chamber with one that has a different temperature range. Relevant questions: A1. Add, remove, or change a component/part/material that directly or indirectly contacts body tissue? No. The tissue specimens have been removed from the human body, are within a sealed container, and neither the water bath nor heating chamber directly or indirectly contacts the tissue.
A2 Add or remove component/part/material or change the dimensional or performance specifications of a component/part/material? Yes. The heating chamber was removed and replaced. The heating chamber’s performance specifications were changed because the new heating chamber has a different temperature range.
A2.1 Is there a significant change to device performance or safety specifications? Yes. The performance is significantly changed because the heating range extends beyond that of the heating chamber in the legally marketed device.
Decision: Remanufacturing.
Example E.7 Activity: A stainless steel manual drill is intended to be used in the implantation of orthopedic devices. The drill is intended to be reprocessed and reused for multiple procedures. The drill was sharpened because it is dull and difficult to use. This is the first time the drill has been sharpened.
Relevant questions: A1. Add, remove, or change a component/part/material that directly or indirectly contacts body tissue? Yes. Sharpening the drill removes material and exposes a fresh surface that directly contacts bone.
A1.1 Is there a significant change to device performance or safety specifications? No. The drill is not coated. The material and structure of the drill that contacts body tissue is uniform. A risk-based assessment concluded that removal of material due to sharpening as well as the sharpening process itself does not significantly change the biocompatibility or reprocessing.
A2. Add or remove component/part/material or change the dimensional or performance specifications of a component/part/material? Yes. Sharpening of the drill removes material changing the dimensions of the drill.
A2.1 Is there a significant change to device performance or safety specifications? No. The drill was returned to its performance and safety specifications because the entity sharpened the device to its labeled outer diameter and original edge profile angle. A3. Is there a new or modified risk or is there a change in the performance or safety specifications? Yes. Sharpening the drill may change the size of the resulting pilot drill hole. Changing the size of the pilot hole can change the fit of the implant or overall purchase in bone such that the mechanical integrity of the implant is compromised.
A3.1 Is there a significant change to device performance or safety specifications? No. Based on the facility’s maintenance record, it was determined that this is the first drill sharpening. The drill produces the same pilot hole size as the legally marketed device after the sharpening has been completed. There is no significant change to the device’s performance or safety specifications at this time.
Decision: Not Remanufacturing.
Activity: A stainless steel manual drill with a titanium nitride coating is intended to be used in the implantation of orthopedic devices. The drill is intended to be reprocessed and reused for multiple procedures. The drill was sharpened because it is dull and difficult to use. The drill has been sharpened multiple times.
Relevant questions: A1. Add, remove, or change a component/part/material that directly or indirectly contacts body tissue? Yes. Sharpening the drill removes material and exposes a fresh surface that directly contacts bone.
A1.1 Is there a significant change to device performance or safety specifications? No. While sharpening the drill exposes the stainless steel surface beneath the coating, both the surface coating and underlying stainless steel have been subjected to a biocompatibility assessment. Additionally, a risk-based assessment concluded that removal of material due to sharpening does not significantly change the biocompatibility or reprocessing.
A2. Add or remove component/part/material or change the dimensional or performance specifications of a component/part/material? Yes. Sharpening of the drill removes material changing the dimensions and cutting surface of the drill.
A2.1 Is there a significant change to device performance or safety specifications? Yes. Based on the facility’s maintenance record, it was determined that the drill has been sharpened multiple times. While the outer diameter of the drill is not significantly changed from the legally marketed device, the titanium nitride coating is no longer intact on the cutting surface of the drill, causing inefficient or destructive cutting. This activity significantly changes the device’s performance and safety specifications.
Decision: Remanufacturing. Example E.8 Activity: The lens of an endoscope is cracked. The lens is affixed by an epoxy that is not described in the labeling. The cracked lens was removed and replaced. The epoxy used was purchased from the OEM and is identical to that used in the legally marketed device. The replacement lens was not purchased from the OEM. The lens was tested and demonstrated to have the same optical specifications (e.g., focal length, Abbe number) and materials as the original lens.
Relevant questions: A1. Add, remove, or change a component/part/material that directly or indirectly contacts body tissue? Yes, both the lens and the epoxy directly contact body tissue.
A1.1 Is there a significant change to device performance or safety specifications? No. The epoxy is identical to the epoxy used in the legally marketed device. The replacement lens is the same material as original lens. A risk-based assessment that considered both the individual and cumulative changes was performed to determine if the procedure used to replace the lens affects biocompatibility and reprocessing instructions. A biocompatibility assessment confirmed that there are no new surfaces previously unexposed to body tissue. A comprehensive reprocessing risk assessment and testing demonstrated that the validated reprocessing instructions identified in the labeling of the legally marketed device are not impacted by the replacement parts or the procedure used to replace the parts.
A2. Add or remove component/part/material or change the dimensional or performance specifications of a component/part/material? Yes. The epoxy and lens were replaced.
A2.1 Is there a significant change to device performance or safety specifications? No. The optical performance testing (e.g., resolution and distortion) and reprocessing risk assessment and testing indicated there has been no significant change in performance or safety specifications.
A3. Is there a new or modified risk or is there a change in the performance or safety specifications? No. A risk-based assessment was performed that considered both the individual and cumulative changes that could have affected biocompatibility, reprocessing, and optical performance. This assessment identified that there are no new or modified risks, and there is no change in performance or safety specifications.
Decision: Not Remanufacturing.
Activity: The lens of an endoscope is cracked. The lens is affixed by an epoxy that is not described in the labeling. The cracked lens was removed and replaced. The epoxy used was purchased from the OEM and is identical to that used in the legally marketed device. The replacement lens comes from a different endoscope model from the same OEM; that model was 510(k)-cleared with improved optical performance (e.g., resolution and distortion) relative to the original endoscope. The replacement lens has the same material but different optical specifications (e.g., focal length, Abbe number) from the original.
Relevant questions: In this example, the answers to flowchart questions A1, A1.1, and A2 are the same as Example E.8.a.
A2.1 Is there a significant change to device performance or safety specifications? Yes. The epoxy is identical to that used in the legally marketed device, but the lens has different optical specifications from the original lens. The endoscope with the replacement lens has different imaging specifications relative to the legally marketed device. While the replacement lens is present on another 510(k)-cleared device, it was not present on the original endoscope and significantly changes the performance specifications of the original endoscope.
Decision: Remanufacturing.
Example E.9 Activity: An endoscope’s connection to the video processor was damaged during use. After repair, it was observed that the endoscope readily disconnected from the video processor. To address this problem, an adapter was added to reduce the probability of a disconnection between the endoscope and video processor. The adapter was found to be capable of connecting to the video processor; however, it is bulkier than the connector.
Relevant questions: A1. Add, remove, or change a component/part/material that directly or indirectly contacts body tissue? No. The added adapter does not directly or indirectly contact body tissue.
A2. Add or remove component/part/material or change the dimensional or performance specifications of a component/part/material? Yes, the adapter has been added to the endoscope.
A2.1 Is there a significant change to device performance or safety specifications? No. The adapter still allows the endoscope to be connected to the video processor and optical performance testing demonstrated the same optical performance as the original endoscope.
A3. Is there a new or modified risk or is there a change in the performance or safety specifications? Yes. A risk-based assessment was performed to determine the effects of this added component. Increased risks exist with the added adapter, such as disconnection from the light source, and the potential change to the electrical safety and electromagnetic compatibility (EMC) of the device.
A3.1 Is there a significant change to device performance or safety specifications? Yes. Disconnection from a light source during a procedure could result in a loss of imaging and adverse events such as increased procedure time or other patient injuries such as perforation. Additionally, testing should also be performed for the electrical safety and EMC of the device.
Decision: Remanufacturing.
Example E.10 Activity: The motor on a powered wheelchair no longer functions and does not propel the wheelchair as intended. The motor was inspected and it was determined that the motor should be replaced. Neither the identical motor nor one with similar specifications could be located. A motor of similar size was inserted with different power and speed specifications.
Relevant questions: A1. Add, remove, or change a component/part/material that directly or indirectly contacts body tissue? No. The motor does not directly or indirectly contact body tissue.
A2. Add or remove component/part/material or change the dimensional or performance specifications of a component/part/material? Yes. The original motor was removed and replaced.
A2.1 Is there a significant change to device performance or safety specifications? Yes. While the motor has the same physical dimensions, the replacement motor has a different power output and maximum speed than the legally marketed device. This significantly changes the device’s performance specifications because the wheelchair can go faster than intended. This also significantly changes the device’s safety specifications because the controller and software to operate the wheelchair may no longer be compatible with the motor.
Decision: Remanufacturing.
Example E.11 Activity: The liquid cooling system responsible for maintaining the temperature of a transcranial magnetic stimulation (TMS) coil is malfunctioning and causing the system to overheat. The cooling system was inspected and it was determined that the pump circulating the liquid coolant stopped functioning. A replacement pump was located and installed with no additional changes to the device.
Relevant questions: A1. Add, remove, or change a component/part/material that directly or indirectly contacts body tissue? No. The liquid coolant is maintained in the sealed coolant system and neither the liquid coolant nor the pump directly or indirectly contacts body tissue.
A2. Add or remove component/part/material or change the dimensional or performance specifications of a component/part/material? Yes, the pump was replaced. A2.1 Is there a significant change to device performance or safety specifications? No. Both the dimensions and performance specifications of the original pump were assessed in comparison to the replacement part. The replacement pump has the same dimensional and performance specifications of the original pump. The overall performance and safety specifications of the TMS coils were verified by testing to be the same.
A3. Is there a new or modified risk or is there a change in the performance or safety specifications? No. A risk-based assessment identified no new or modified risks because the replacement pump is equivalent to that used in the OEM’s legally marketed device and there is no change in the device performance or safety specifications.
Decision: Not Remanufacturing.
Activity: The liquid cooling system responsible for maintaining the temperature of a TMS coil is malfunctioning and causing the system to overheat. The cooling system was inspected and it was determined that the pump circulating the liquid coolant stopped functioning. A replacement pump was located with the same size and flow specifications, but it uses a different coolant liquid. The pump was replaced with one that uses a different coolant into the cooling system.
Relevant questions: In this example, the answer to flowchart question A1 is the same as Example E.11.a.
A2. Add or remove component/part/material or change the dimensional or performance specifications of a component/part/material? Yes. A replacement pump that uses a different coolant liquid was installed.
A2.1 Is there a significant change to device performance or safety specifications? Yes. Although the pump has the same dimensional and flow specifications as the original pump, the new pump uses a different liquid coolant. The new liquid coolant does not have the same heat capacity as that used in the legally marketed device. Verification and validation testing was performed and it was determined that there was a significant change to cooling effectiveness, which poses a safety hazard when the TMS coil is not properly cooled. This may burn the patient or cause further device malfunctions.
Decision: Remanufacturing.
Example E.12 Activity: An energy-delivering aesthetic device has multiple compatible handpieces with specific areas of application. Applicator A can only be used for the chin, while Applicator B can only be used on the abdomen. An entity cannibalizes Applicator B and uses those parts to repair Applicator A for use on the chin. Relevant questions: A1. Add, remove, or change a component/part/material that directly or indirectly contacts body tissue? Yes. The distal end of Applicator B is used to reconstruct Applicator A. It directly contacts the patient and delivers the energy.
A1.1 Is there a significant change to device performance or safety specifications? No. The distal end of both applicators has identical materials and the reprocessing instructions provided by the OEM are the same for both applicators. A risk-based assessment was performed to determine the effects of implementing these repairs on the biocompatibility and reprocessing. A biocompatibility assessment and reprocessing risk assessment were used to determine that the performance and safety specifications of the device were not significantly changed.
A2. Add or remove component/part/material or change the dimensional or performance specifications of a component/part/material? Yes. The distal end of Applicator B has different dimensional specifications compared to Applicator A.
A2.1. Is there a significant change to device performance or safety specifications? Yes. The surface area that contacts the patient has increased by 150%. The increase in surface area changes the energy output delivered to the patient, which significantly changes both the performance and safety specifications of Applicator A.
Decision: Remanufacturing.
(2) Software activities Example S.1 Activity: A specular microscope with a camera is intended for examination of corneal endothelium and for measurement of the thickness of the cornea. The software was updated to implement an OEM-authorized patch.
Relevant analysis: The installation of this OEM-authorized patch does not significantly change the device performance or safety specifications. See Section VII of this guidance for further discussion of changes involving software. The patch is intended to maintain the original specifications.
Decision: Not Remanufacturing.
Example S.2 Activity: A device has the capability of real-time remote customer service where the current status of the device can be accessed. A capability is added so that the customer service technician can access and directly manipulate the device, including changing device settings, resetting the device, delivering energy, and positioning the device. Relevant analysis: The capability of the customer service technician to control the device introduces new risks (e.g., accidental device reset, unintended device movement) and functionality (remote control and access) that significantly changes the finished device’s performance and safety specifications.
Decision: Remanufacturing.
Example S.3 Activity: A device that connects to a facility’s network has software that was designed to run the Microsoft Windows operating system (OS). Adjustments are made to allow the device to run using a Linux OS.
Relevant analysis: This change introduces new risks and may impact mitigations for existing risks that significantly change the finished device’s performance and safety specifications. This is a redesign of the product and includes the addition of integration with both device drivers for the target OS as well as specific features of the OS.
Decision: Remanufacturing. Appendix B. Documentation Examples The examples below are to illustrate one possible approach to documentation; other approaches may also be appropriate. Entities are encouraged to use an approach that works for their specific purposes, taking into account the considerations discussed above. Rationale documentation may also be incorporated into existing procedures, forms, and other documents when appropriate. The first example demonstrates a simple change that does not necessitate detailed analysis. The second example demonstrates a more complex change for which additional analysis and reference to supporting documentation are warranted. These are generalized examples to demonstrate documentation principles and do not necessarily account for every possible detail, risk, or consideration.
Remanufacturing Assessment (Example 1)
Product: Pump ABC
UDI: (01)51022222233336(11)141231(17)150707(10)A213B1(21)1234
Date of activities performed: 12/11/2018
Date assessment completed: 12/10/2018
Description of device: Syringe pump
Description of activities performed: Replaced broken door with part #xxx
Determination of whether the activity is remanufacturing: While a change to a body contacting component, the door used was OEM-provided and is identical to the broken door. Because it is a replacement of an identical part, there are no changes to performance or safety specifications. This activity is not remanufacturing.
Reference to related documents supporting the decision-making process: N/A
Technician performing service: xxx
Reviewed by: xxx
Signature(s): xxx Remanufacturing Assessment (Example 2)
Product: Endoscope Infinity
UDI: +H123PARTNO1234567890120/$$420020216LOT123456789012345SXYZ45678901234567 8/16D20130202C
Date of activities performed: 9/24/2018-9/30/2018
Date assessment completed: 10/1/2018
Description of device: Flexible endoscope
Description of activities performed: Repair device; lens, irrigation channel, and shaft exterior replaced. Each change was individually and cumulatively assessed.
Determination of whether the activity is remanufacturing: Lens Assessment • Original lens is cracked and needs replacement; OEM lens and epoxy not available for purchase; • Equivalent lens with same performance specifications and dimensions used (see biocompatibility assessment (BCA) #EI-001 and Component Comparative Analysis Report (CCAR) #EI-002); • Epoxy used to secure lens is equivalent to OEM epoxy (see BCA #EI-003 and CCAR #EI-004); and • Leak, optics, and field of view were verified to be within OEM specifications.
Irrigation Channel Assessment • Irrigation channel is worn and leaking fluid into the device; • OEM part available for purchase and used (part #XX44); and • Irrigation channel installed and checked for leaks and functionality.
Shaft Exterior Assessment • Shaft exterior damaged during repair activities and needs replacement; • OEM part not available for purchase; and • Equivalent shaft exterior with same performance specifications and dimensions used (see BCA #EI-005 and CCAR #EI-006).
Cumulative Change Assessment • Full device specification list inspected and passed (see Customer Evaluation Report #88239 and OEM specification sheet); • No change in component exposure to reprocessing when following OEM reprocessing instructions; • A risk-based assessment was performed in each CCAR report; modified risks were identified with using non-OEM parts but were demonstrated as not significantly changing the device’s performance or safety specifications, or intended use; and • No other change in the risks, or change in the performance or safety specifications, have been identified for the cumulative changes made.
This activity is not remanufacturing.
Reference to related documents supporting the decision-making process:
- BCA #EI-001
- CCAR #EI-002
- BCA #EI-003
- CCAR #EI-004
- BCA #EI-005
- CCAR #EI-006
- Customer Evaluation Report #88239
- Endoscope Infinity Specification Sheet
Technician performing service: xxx
Reviewed by: xxx
Signature(s): xxx
Footnotes
[^52]: See sections 510(h)(1), 702, and 704 of the FD&C Act.
[^53]: See section 510(h)(4) of the FD&C Act for the risk-based factors FDA considers during inspectional planning.
[^57]: See 21 CFR 803.50 and part 1002.
[^58]: For more information, see FDA’s guidance, “Medical Device Reporting for Manufacturers,” available at https://www.fda.gov/medical-devices/postmarket-requirements-devices/mandatory-reporting-requirements- manufacturers-importers-and-device-user-facilities.
[^59]: See 21 CFR 806.10(a). However, no report is required if the information has already been submitted to FDA under 21 CFR part 803 (Medical Device Reporting) or 21 CFR part 1004 (Repurchase, Repairs, or Replacement of
[^60]: See 21 CFR 806.20.
[^61]: See 21 CFR 1003.10. However, no notification is required if the information has already been submitted to FDA under 21 CFR part 803 (Medical Device Reporting). Electronic devices subject to notification under 21 CFR 1003.10(b) are also subject to requirements under 21 CFR part 1004.
[^62]: See 21 CFR part 7. request of FDA.63 21 CFR part 7 provides guidelines so that responsible firms may conduct an effective recall, including information to report to FDA and communicating about the recall. In rare instances, where the manufacturer or importer fails to voluntarily recall a device that is a risk to health, FDA may issue a recall order to the manufacturer under 21 CFR part 810, Medical
[^64]: 21 CFR part 810 describes the procedures FDA will follow in exercising its medical device recall authority under section 518(e) of the FD&C Act.
[^66]: FDA has determined that certain types of medical devices are exempt from GMP requirements. These devices are exempted by FDA classification regulations published in the Federal Register and codified in 21 CFR 862 to 892.
[^67]: Section 201(m) of the FD&C Act.
[^69]: See sections 502(a), 201(n), 502(c), and 502(f)(2) of the FD&C Act. A device shall be deemed misbranded if, among other things: its labeling is false or misleading; its labeling does not contain adequate warnings; or any information required to be in the labeling is not prominently placed with such conspicuousness and in such terms to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
[^70]: Section 502(f)(1) of the FD&C Act requires that labeling bear adequate directions for use. For non-prescription devices, adequate directions for use include instructions on preparing a device for use. 21 CFR 801.5(g).