As highly regulated, complex life-saving instruments, medical imaging devices are subject to FDA regulatory oversight throughout their lifecycle.
These devices require regular servicing to ensure they are functioning properly. These activities, if performed properly, include: routine preventive or planned maintenance; replacement of worn parts with parts that have undergone verification and validation; cleaning, disinfecting, or sterilizing equipment; deploying patches or upgrading software that has undergone verification and validation; application of unfilled engineering change orders or field modifications that have undergone verification and validation; installation, de-installation, and relocation of devices; and refurbishment of medical devices to “like new” conditions.
However, if servicing is done improperly, it may constitute remanufacturing. Remanufacturing is an FDA-regulated activity in which a medical device is altered in such a way that there is significant risk that the device will no longer function as originally FDA-approved and intended.
Remanufacturing encompasses activities that result in changes to any of the following: sterilization methods; reprocessing instructions; control mechanisms; operating principle; energy input or output; or design. These activities could change the performance or safety specifications or intended use of the finished device.
A 2018 FDA report called attention to remanufacturing activities that had previously escaped oversight and launched an FDA process to bring greater scrutiny to the issue.
Unfortunately, the definition of remanufacturing as currently written is vague, leading to instances of remanufacturing escaping FDA oversight and creating patient safety, device performance, and cybersecurity concerns.
Proposed legislation, the Clarifying Remanufacturing to Protect Patient Safety Act (H.R. 7253), would bring greater clarity to remanufacturing regulations and provide necessary oversight of remanufactured medical devices to protect the health and safety of patients and healthcare providers.
By clarifying what “remanufacturing” means, the proposed legislation seeks to:
- Empower all stakeholders to make informed decisions about the nature of their activities and corresponding regulatory responsibilities.
- Enable FDA to foster a more transparent industry by bringing appropriate oversight to all remanufacturing activities.
- Avoid potentially dangerous scenarios where certain medical devices could have vital safety, cybersecurity or performance properties changed without proper oversight or accountability.
- Amplify work that FDA is already doing regarding clarifying and scrutinizing remanufacturing activities.
MITA strongly supports this commonsense solution and encourages Members of Congress to pass this legislation without delay.