FDA Seeks to Publish Guidance on Servicing, Remanufacturing of Devices by Fall 2019

Posted June 7, 2019

The Food and Drug Administration (FDA) is hoping to publish a draft guidance document by Sept. 30, 2019, that will help clarify the differences between the servicing and remanufacturing of medical devices.

The announcement was made during an update provided by Katelyn R. Bittleman, PhD, a consumer affairs officer in the FDA's Center for Devices and Radiological Health, during the HTM Annual Leadership Exchange (HALE) meeting on Friday, June 7, during the AAMI Exchange in Cleveland, OH.

The draft guidance would be the next offering from the FDA in its ongoing efforts to facilitate improvements in the quality, safety, and effectiveness of servicing of medical devices. These efforts have included:

  • In May 2018, the agency concluded that evidence was insufficient to justify imposing additional regulations on third-party servicers of medical devices. The announcement coincided with the publication of a highly anticipated report on the quality, safety, and effectiveness of medical device servicing that was required as part of the FDA Reauthorization Act of 2017.
  • In October 2018, the FDA published a white paper titled "Evaluating Whether Activities are Servicing or Remanufacturing." In addition to describing the agency's initial thoughts about guiding principles, Bittleman said the white paper includes a flowchart, accompanying text, and a complementary approach for software to distinguish servicing from remanufacturing. The paper further includes considerations for labeling and examples for discussion.
  • In December 2018, the agency held a public workshop to discuss the framework for the draft guidance document.

Ultimately, said Bittleman all relevant stakeholders—original equipment manufacturers, independent service organizations, and in-house healthcare technology management (HTM) professionals—need to focus on establishing a collaborative community to achieve common ground on the long-standing servicing debate.

Dave Francoeur, senior vice president of marketing and sales for Tech Knowledge Associates LLC and co-chair of the HALE, concurred with Bittleman. "FDA isn't going to mandate actions on the part of any one stakeholder," he said. "Ultimately, they are looking for parties to come together to determine the best course of action, then FDA can support that strategy going forward." Alongside Bittleman, Francoeur has been involved in launching the collaborative community.

Attendees of the HALE meeting also pointed out that CMMS (computerized maintenance management system) vendors—given the valuable data they possess—and other key stakeholders need to be part of the collaborative community.

In addition to clarifying the difference between servicing and remanufacturing, the FDA is pursuing other service-related actions, as summarized in the May 2018 publication:

  1. Promoting the adoption of quality management principles by medical device servicers. Bittleman emphasized the importance of documentation and avoiding recurrent adverse events. Guidance such as ANSI/AAMI/ISO 13485:2016, Medical devices—Quality management systems—Requirements for regulatory purposes, can help organizations design a quality management system that establishes and maintains the effectiveness of their processes.
  2. Strengthening cybersecurity practices associated with servicing of medical devices
  3. Fostering evidence development to assess the quality, safety, and effectiveness of medical device servicing

Although the FDA seeks to publish the draft guidance by fall of this year, the release date could be pushed back as a result of a memo issued by the Office of Management and Budget (OMB) outlining how the OMB’s Office of Information and Regulatory Affairs will be granted further jurisdiction in the regulatory processes of all agencies.

To determine whether proposed rules are “major” or “minor," the memo requires agencies to submit regulations and official guidance to the Office of Information and Regulatory Affairs for review. If proposed rules are deemed major, they must then be reviewed by Congress.

"I don't know what's going to happen," Bittleman said.

Formerly known as the Manny Meeting, the yearly HALE meeting provides HTM leaders with a forum for exploring solutions to challenges facing the field.