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MITA White Paper Clarifying Distinction Between Medical Imaging Device

Servicing and Remanufacturing

Washington, DC, February 07, 2019 --(PR.com)-- The Medical Imaging & Technology Alliance (MITA)
today announced the release of a white paper outlining a framework for establishing the distinction
between servicing and remanufacturing activities for medical imaging devices.

The paper, titled “Considerations for Remanufacturing of Medical Imaging Devices,” calls on the U.S.
Food and Drug Administration (FDA) to clarify the distinction between servicing and remanufacturing
and offers detailed descriptions of the types of activities that would constitute either. Further, the white
paper recommends that organizations adopt appropriate quality management systems to define the nature
and scope of the activities they are undertaking. This is to ensure servicing and remanufacturing activities
are properly performed, documented, and regulated.

In a May 2018 report to Congress, the FDA expressed its intent to develop draft guidance on
remanufacturing of medical devices.

“We hope this white paper will serve as a resource for the FDA and the broader stakeholder community
as it moves forward with future guidance on this issue,” said Dennis Durmis, Chair of MITA's Board of
Directors. “It is important that a sound process and clear definitions are in place to ensure that servicing
activities are clearly distinguished from remanufacturing and all stakeholders understand the differences.”

According to the MITA white paper, medical device “servicing” should be defined explicitly as:

Preventative maintenance, calibration, or repair of a finished medical device after distribution for
purposes of maintaining it within or returning it to the safety and performance specifications established
by the OEM and to meet its original intended use. Servicing cannot change the intended use(s) of the
device from its original purpose(s).

Currently, third-party medical device servicers are not required to have controls in place to determine if
their servicing activities constitute remanufacturing as defined by the FDA. While the FDA does regulate
the remanufacturing of medical devices, it does not regulate servicing activities and has few safeguards in
place to ensure that servicing activities do not cross over into uncontrolled and unregulated
remanufacturing. This lack of oversight poses an increased risk to public health and thus the safety of
patients and device users.

In December 2018, the FDA held a public workshop to discuss the distinction between servicing and
remanufacturing to better inform the development of future guidance on this issue. The workshop was
accompanied by the release of the agency's white paper, which acknowledged the need for clarification
between the two activities.

“We look forward to working with the FDA and industry stakeholders in the coming months to ensure the
third-party servicing of devices is done in a manner that maximizes patient health and safety,” Durmis

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The Medical Imaging & Technology Alliance (MITA), a division of NEMA, is the collective voice of
medical imaging equipment manufacturers, innovators, and product developers. It represents companies
whose sales comprise more than 90 percent of the global market for advanced medical imaging
technology. Visit medicalimaging.org. Follow MITA on Twitter @MITAToday.----

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Contact Information:
Medical Imaging and Technology Alliance
Tracy Cullen
Contact via Email

Online Version of Press Release:

You can read the online version of this press release at: https://www.pr.com/press-release/776575

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