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16th Annual Medical Device Quality Congress

Servicing & Remanufacturing


Date: April 24, 2019

Time: 9:00AM - 10:00AM

Location: Bethesda, MD

Ben Zegarelli and Aaron Josephson will be speaking on a panel entitled, "Servicing & Remanufacturing" at the 16th Annual Medical Device Quality Congress.

In December 2018, the FDA hosted a public workshop on medical device servicing and remanufacturing and solicited comments that the agency will use in developing a draft guidance clarifying the difference between the two activities. This session will include an overview of the regulatory and legislative history of device servicing, a debrief of the December 2018 public workshop, a review of the comments submitted to the public docket, and an exploration of alternative commercial models related to servicing.
This panel will discuss the outcomes of the workshop and provided best practices for the following questions:

•Are there additional considerations that may help entities distinguish between servicing and remanufacturing activities?
•What are acceptable methods of assessing component/part/material specifications during servicing or remanufacturing?
•What are the pros and cons of the risk-based approach discussed in this white paper?


Benjamin M. Zegarelli is a Mintz Associate who counsels clients on compliance and regulatory issues, with a focus on FDA regulations. Benjamin advises clients in the pharmaceutical, medical device, and biotech industries. He provides counsel on research approval, sales, and contract negotiations.
Aaron L. Josephson is a Senior Director of ML Strategies who advises clients on health care policy issues related to medical devices and pharmaceuticals. Earlier, he was with the US Food and Drug Administration, including as a senior policy advisor in the Center for Devices and Radiological Health.