Remanufacturing of Medical Devices Guidance for Industry, Entities That Perform Servicing or Remanufacturing, and Food and Drug Administration Staff Document issued on May 10, 2024.
Summary for Acertara customers
The FDA guidance issued last week is a fresh and clarifying look at how to distinguish between repair and remanufacturing. The guidance document seeks to help companies engaged in these activities to understand how to interpret the existing laws that govern repair and remanufacturing. One key takeaway for Acertara customers is that repair and remanufacturing might involve identical activities, but the distinction between the two lies in the results of quantitative testing.
This means that suppliers in repair or remanufacturing must have comprehensive quantifiable testing that supports their service demonstrating that they either conform to the OEM specifications or they conform to the FDA 510(k) guidelines and have submitted a new 510(k) for that activity.
If you are not sure if supplier has this testing, please don’t take their word for it – you must verify it, your hospital is at risk both from a disruption from the FDA enforcing the law against suppliers who are violating this law, and in commissioning improper service creating a risk of lawsuits and other risks that could damage your hospital.
Acertara is in full compliance with the regulations and guidance.
This regulation and guidance does not apply to HTMs who are working directly for the healthcare delivery provider.
Remanufacturing
This occurs when a device has a component added or removed that significantly affects its safety, efficacy, or intended clinical use. Essentially, the device is not returned to the Original Equipment Manufacturer (OEM) specifications. In such cases, the remanufacturer is no longer a service provider, rather they take on the regulatory responsibilities of an OEM. This includes completing the testing and regulatory filings associated with a 510(k) submission for each model of device they intend to service, encompassing all intended service activities for that device. Additionally, remanufacturers must adhere to labeling requirements, adverse event reporting (MDR), and other regulatory obligations.
The guidance document is clear that any service activity that is not supported by documented comprehensive testing and verification that demonstrates substantial equivalence to the OEM specifications is by definition remanufacturing1 as a change that is unsupported by testing and risk analysis cannot be determined to be substantially equivalent to an OEM specification.
Repair
This is defined as adding or removing a component that may or may not significantly affect the device’s safety, efficacy, or intended clinical use, and will return the device to OEM specifications. The service provider must still conduct quantitative testing to demonstrate that
the repair restored the device to OEM specifications. This testing includes many of the same tests required for 510(k) clearance. For example, establishing a comparison benchmark by performing comprehensive testing of an OEM probe that has all of its original components, has not been repaired, and is a valid functional representative sample of the probe model population in circulation. Such analysis must be conducted on a statistically relevant number of samples. Proper documentation of the decision-making process and risk assessments is essential.
In both cases, i.e. remanufacturing and servicing, ongoing testing must be conducted according to a sampling plan to demonstrate that there is an appropriate correlation between the qualification samples and production samples.
Acertara is the only probe repair company, based on the information we’ve seen to date, that has adhered to these requirements. We have performed this testing to support our repairs before these regulatory requirements were enacted because we strongly believe that these activities are critical to ensuring patient safety and sustainable repairs: Acertara was built on these ideals.
Details of the testing we conduct are available for our customers to view in person. A partial list of the standards we follow in the testing we conduct for our repair activities is shown below, as is an example of the actual test reports we generate for every probe we repair:
(1) IEC 60601-1 – General requirements for basic safety and essential performance
(2) IEC 60601-1-2 – Electromagnetic compatibility requirements and tests
(3) IEC 60601-2-37 – Particular requirements for the safety of ultrasound devices
(4) IEC 62353 – Test after repair of medical electrical equipment
(5) ISO 10993-1 – Biocompatibility of patient contact materials
(6) IEC 62359 – Acoustic power (see #6)
(7) FDA Ultrasound Submission Guidance
If you have questions about the regulation, guidance, or probe service please reach out to us. Please contact your suppliers and ensure that they have the comprehensive testing necessary to adhere to the law – your organization could be the one who pays the price for negligence in this area.
Questions and Comments about the FDA Remanufacturing of Medical Devices Guidance or Acertara accreditation should be directed to Levi Moore, B.Sc., MBA, President & CEO at Acertara. [email protected] 303.834.8413
1 Section V. Guiding Principles, subsection 4.
“Assess component/part/material28 dimensional and performance specifications – Assessment of changes to dimensional and performance specifications can inform whether the activity performed is remanufacturing. The impact of component/part/material changes can be evaluated by comparison to the OEM components/parts/materials specifications and/or through verification and validation testing. Deviations in component/part/material specifications from the OEM’s legally marketed device may result in significant changes to the device’s performance or safety specifications, and may necessitate closer evaluation, such as conducting an engineering analysis, verification and/or validation testing, or a risk-based assessment, and consideration of the regulatory criteria describing when a new marketing submission is required.”