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FDA Guidance Calls for Quantitative Testing

The U.S. Food and Drug Administration (FDA) recently issued Final Guidance on the definition and determination of what constitutes “remanufacturing” for reusable medical devices. This update aims to ensure consistency and adherence to federal regulations by original equipment manufacturers (OEMs) and third-party suppliers, distinguishing remanufacturing from servicing. This distinction clearly outlines the regulatory guidance entities should follow. For Acertara, this update reinforces practices we’ve long championed, such as maintaining rigorous standards for quantitative testing and compliance, ultimately ensuring patient safety across the healthcare sector.

Implications of the FDA’s Final Guidance

The FDA’s Final Guidance provides a comprehensive definition of what constitutes remanufacturing, describing it as any process that significantly alters a device’s performance, safety specifications, or intended use. In contrast, servicing is the repair or routine maintenance of parts to return a device to its original OEM defined specifications without altering its fundamental performance or safety profile.

Activities that are considered remanufacturing require the same level of oversight as new device manufacturing, including adverse event reporting, registration, and pre-market submissions. Meeting the safety and performance specifications established by the OEM is paramount, as deviations can result in regulatory noncompliance and potential risks to patient safety.

The Final Guidance explicitly states that hospital personnel are not included in this guidance, ensuring a clear delineation of responsibilities. This focus on OEMs and third-party suppliers underscores the importance of maintaining high standards in device servicing and remanufacturing.

So, what can suppliers do to ensure compliance? They’ll need to integrate quantitative testing into their operations.

Quantitative testing is essential

Quantitative testing involves precise measurements and statistical analysis to validate that medical devices meet their original specifications and regulatory guidance post repair. This type of testing is vital to demonstrate compliance with the FDA’s Final Guidance because it provides objective, reproducible data that ensures devices maintain their safety, intended use, and essential performance standards.

• Servicing ultrasound devices: Quantitative testing includes various methodologies such as electrical testing, acoustic performance measurement, and material analysis. These processes contrast with qualitative testing methods that rely on subjective assessment, offering a higher degree of accuracy, reproducibility, and reliability.
• Avoiding unintentional remanufacturing: By ensuring that devices meet OEM safety and performance specifications, quantitative testing helps prevent unintentional remanufacturing by revealing substantial variances in specifications. This is crucial because any significant alteration in device performance can lead to noncompliance with federal law and lead to potential safety risks.

Quantitative testing supports the total product lifecycle of medical devices by continuously validating their performance and safety parameters. It’s rigorous, it’s reliable, and it’s the right thing to do when patient care and device safety are on the line.

Accredited testing services

Acertara’s history and expertise in quantitative testing make us an ideal partner for hospitals, OEMs, and third-party suppliers. Our services include acoustic measurement, calibration, and comprehensive testing of ultrasound devices to ensure they meet FDA guidance.

We offer a range of testing services, including the use of advanced diagnostic tools like our ATLAS ultrasound probe tester and AmpSafe for electrical leakage testing. These tools provide detailed analyses of device performance, helping to maintain compliance and enhance patient safety.

Partnering with an accredited testing service like Acertara ensures compliance with the FDA’s Final Guidance. Our ISO/IEC 17025:2017-accredited laboratory is equipped with state-of-the-art technology and staffed by experts in ultrasound engineering and regulatory compliance.

By using Acertara’s services, organizations can ensure their devices comply with the latest regulatory standards. Our technical acumen for quantitative testing, deep knowledge of ultrasound technology, and thorough insight into regulatory requirements have positioned us as a leader in the field for decades. And we’ve always been thrilled to help our partners do the same, especially when it means improving patient safety.

Acertara’s ultrasound testing services: Reliability meets compliance

The FDA’s Final Guidance on device remanufacturing establishes a clear differentiation between servicing and remanufacturing, emphasizing rigorous quantitative testing to ensure devices meet OEM specifications, avoid unintended remanufacturing, and comply with applicable FDA regulations. As the industry adapts, partnering with trusted providers like Acertara becomes essential. Our proven track record in quantitative testing for ultrasound devices makes us an ideal partner for anyone navigating these new guidelines. By leveraging our expertise, OEMs and third-party suppliers can ensure the safety, effectiveness, and efficacy of their devices with full peace of mind.