FDA to Host Workshop on Medical Device Servicing and Remanufacturing

Posted October 23, 2018

The Food and Drug Administration (FDA) has opened registration for a public workshop on Dec. 10–11 as part of what it describes as “the agency’s continued commitment to promoting high-quality, safe, and effective medical device servicing and remanufacturing.”

The workshop, which will be held in Gaithersburg, MD, is intended as a public discussion about the distinction between medical device servicing and remanufacturing activities to inform the development of future draft guidance. Due to expressed interest from industry, the workshop also will be a forum to discuss opportunities to increase collaboration between the FDA and manufacturers, healthcare establishments, and independent service organizations.

Patrick Bernat, standards director at AAMI, said AAMI is developing a standard that relates to the FDA activity on the service front.

“Over the last couple of years, the FDA has expressed a keen interest in clarifying definitions of terms related to the servicing of devices, as evidenced by this newly announced workshop,” said Bernat. “And understandably so. If various stakeholders disagree on the definitions of basic service-related terms, it is difficult to find common ground on substantive issues. So earlier this year, AAMI published a provisional, temporary standard called EQ93 to define several service-related terms. That document is in the process of being advanced as a full American National Standard, so that FDA and other bodies can reference it. And although that standard only defines a few terms, work has already begun on a second edition of EQ93, which will offer a more thorough list of service-related terms and definitions.”

The workshop stems from a report released in May 2018, FDA Report on Quality, Safety, and Effectiveness of Servicing of Medical Devices, which focuses on servicing by original equipment manufacturers and third-party entities, a subject that stirs impassioned debate in the field. At that time, the agency said there was a lack of “objective evidence” to conclude whether there was a widespread public health concern related to device service. As such, the agency said no additional regulatory requirements would be imposed “at this time.”

The FDA also released a white paper, Evaluating Whether Activities are Servicing or Remanufacturing, to guide workshop discussions. The white paper outlines the FDA’s “initial thoughts about guiding principles,” and includes a flowchart, an approach to software, considerations for labeling, and examples.

The agency plans to use the comments from the workshop and on a public docket, which is open until Jan. 25, 2019, to issue the draft guidance that helps determine whether activities are servicing or remanufacturing.

To register for the workshop, access the white paper, and submit comments, visit this page on the FDA website.

The general sessions of the workshop also will be webcast.