Newly Released FDA Ultrasound System and Transducer Guidance
Section 126.96.36.199.8 – Does this Change the 3rd Party Service Question?
G. Wayne Moore, B.Sc., MBA, FASE
The new ultrasound Guidance document, https://www.fda.gov/media/71100/download, addresses, at least in part, two key issues related to the 3rd Party service docket that began some three years ago; specifically who can do service and remanufacturing and what the requirements are. With regard to servicing either systems or probes (aka transducers) the Guidance document (section 188.8.131.52.8 shown above) informs the OEM that they should; “provide information regarding repair of the systems and transducers, and provide instructions to the users on repair and maintenance of the systems and transducers, especially when they are not functioning as designed and intended. For example, the sponsor (i.e., the OEM) may provide instructions for the users that all repair work should be performed by the Original Equipment Manufacturer (OEM). Also, the sponsor may provide instructions to the user to contact the sponsor to obtain a list of third-party repair organizations that are qualified to repair its transducers.” This guidance puts the onus for determining what can be repaired and who can repair it squarely where it belongs; on the OEM. Further, the example used above relative to the user obtaining a list from the OEM of third-parties qualified to repair its transducers implies that the OEM has in fact qualified that third-party through an audit, thereby providing the user with a sense of security that its transducer will be repaired properly.
Regarding the second issue, remanufacturing, the Guidance contains the following, found in Appendix C: “Transducers may be remanufactured by the OEM, or entities other than the OEM. FDA considers transducers that are processed, conditioned, renovated, repackaged, restored, or subjected to any modification that significantly changes its performance or safety specifications, or intended use to be remanufactured. Examples of actions that could be considered remanufacturing are changing the acoustic stack, electrical component, or patient-contact material.” The examples given above “could be” remanufacturing if the changes significantly impact the probes performance, safety, or intended use. To find out what might be a significant change one needs to refer to the consensus standards outlined in the Guidance document (e.g., IEC60601-1, IEC60601-2-37, ISO10993, and so on) and perform comparison testing. If engineering and testing analysis shows a significant change in performance, then the entity must obtain a new 510(k) for the remanufactured device prior to introducing the device into interstate commerce.
The new ultrasound guidance language relative to service and remanufacturing may find its way into the other imaging modalities guidance documents such as CT and MRI; indeed, it may work for most medical devices.
Until Next Month
About the Author, G. Wayne Moore:
A 30-year veteran of the diagnostic ultrasound market Wayne has held senior level positions with several major medical equipment manufacturers, including Honeywell Medical Systems and Siemens Medical Solutions. Wayne has been directly involved in the development and commercialization of more than 15 technologically intensive ultrasound systems. He is widely published in diagnostic ultrasound literature, a sought after speaker at medical imaging conferences, has served as an expert witness in multiple ultrasound litigations, and holds more than 16 United States ultrasound related patents. Wayne obtained his MBA from the University of Denver – Daniels College of Business.
He was elected as a Fellow of the American Society of Echocardiography (FASE) in 2009.
Correspondence: Dave Dallaire
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